Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05688592
Status:
RECRUITING
Last Update Posted:
2023-06-22
First Post:
2022-12-20
Brief Title:
Usefulness of PET-CT for Invasive Fungal Infection
Sponsor:
Puerta de Hierro University Hospital
Organization:
Puerta de Hierro University Hospital
Study Overview
Official Title:
A Prospective Multicenter Study to Determine the Usefulness of Systematic 18-FDG-PET-TC for the Management of Invasive Fungal Infection PETIFI Project
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PETIFI
Brief Summary:
The goal of this national multicenter prospective cohort study is to learn about the added value of 18F-FDG 18F-2-fluoro-2-deoxy-D-glucose PET-CT in invasive fungal disease management The main questions it aims to answer are
1 Does the use of 18F-FDG PET-CT allow a better characterization of invasive fungal infection IFI performance compared to the exclusive use of conventional radiological studies in terms of extensionstaging and monitoring of responsefollow-up
2 Does the systematic and protocolized use of 18F-FDG PET-CT in IFI allow a better management of patients with IFI and increase the prognostic value of the initial evaluation Participants will undergo systematically a 18F-FDG PET-CT as part of the work-up of their invasive fungal disease Researchers will compare the performance of 18F-FDG PET-CT with standard management without 18F-FDG PET-CT to see if adds value diagnostic prognostic and changes in management
1 Does the use of 18F-FDG PET-CT allow a better characterization of invasive fungal infection IFI performance compared to the exclusive use of conventional radiological studies in terms of extensionstaging and monitoring of responsefollow-up
2 Does the systematic and protocolized use of 18F-FDG PET-CT in IFI allow a better management of patients with IFI and increase the prognostic value of the initial evaluation Participants will undergo systematically a 18F-FDG PET-CT as part of the work-up of their invasive fungal disease Researchers will compare the performance of 18F-FDG PET-CT with standard management without 18F-FDG PET-CT to see if adds value diagnostic prognostic and changes in management
Detailed Description:
Design National multicenter prospective cohort study Participating centers 14 Spanish tertiary hospitals see work plan
For inclusion in the study two types of IFIs will be considered
IFI in the form of fungemia detection of fungal growth in blood cultures
Focal IFI with tissue invasion patients with a diagnosis of proven or probable IFI according to the corresponding criteria depending on the type of patient Hematology and other immunocompromised European Organization for Research and Treatment of Cancer EORTCMycoses Study Group Education and Research Consortium MS GERC consensus definitions solid organ transplantation 2010 International Society for Heart and Lung Transplantation ISHLT consensus statements for the definitions of infections in cardiothoracic transplant recipients ICUChronic obstructive pulmonary disease Bulpa criteria COVID-19 Coronavirus disease-2019 ECMM European Confederation of Medical MycologyISHAM
Sample size
Based on the literature we assume that 18F-FDG PET-CT will detect lesions not previously visualized in approximately 50 of patients 7 We anticipate that the findings in 50 of these patients will cause the management of IFI to change which corresponds to 25 of the total number of patients To achieve a 6 accuracy in estimating a proportion using a bilateral 95 Normal asymptotic confidence interval assuming that the proportion is 25 it will be necessary to include 201 patients in the study Assuming 10 of abandonments or loss of information it would be necessary to recruit 224 patients
Period of inclusion of patients in the study 2 years Patient Recruitment Upon suspicion of IFI the attending physician will verify that the patient meets all the inclusion criteria and none of the exclusion criteria and will contact Nuclear Medicine to schedule the performance of 18F-FDG PET-CT according to the deadlines established in the study protocol
Intervention
In addition to the usual management detailed below 18F-FDG PET-TC will be performed to evaluate
staging at diagnosis in the first week after diagnosis preferably in the first 48 hours of starting antifungal treatment
response monitoringfollow-up will be carried out on the same equipment as the initial 18F-FDG 18F-2-fluoro-2-deoxy-D-glucose
PET-TC
in the case of fungemia 2 weeks after the initial staging 18F-FDG PET-CT
in the case of focal IFIs 2-4 and 12 weeks after the initial staging 18F-FDG PET-CT
Data collection and analysis The information shall be collected prospectively by means of a data collection notebook eDCN and stored in an anonymized form in a common database specially designed for the study The data will be obtained from the patients medical history of the different participating centers From the database they will be downloaded to the statistical program for analysis which will be carried out with the support of the Biostatistics Unit of Instituto de Investigación Puerta de Hierro-Segovia did Arana IDIPHISA
Demographic clinical variables and results of conventional diagnostic tests including blood count biochemistry cultures according to presentation biomarkers such as galactomannan or D-glucan and imaging tests x-rays CT MRI or echocardiogram performed according to clinical indication standard of care SOC and following the guidelines will be collected Specifically anatomy-based imaging tests will be performed according to the protocols of each department and will be interpreted by certified specialists radiologists echocardiographists etc as appropriate as part of routine care
Analysis of 18F-FDG PET-CT images
In order to standardize the interpretation of the images in the different participating centers a one-day training session will be held before the start of the study with the participation of all the Nuclear Medicine doctors involved in the project
The 18F-FDG PET-CT will be reviewed by the specialist of the patients center who will be blind to the result of the tests performed according to standard of care SOC Additionally the images will be included in the database for evaluation by a second specialist in Nuclear Medicine from the coordinating center blind for the initial interpretation of the 18F-FDG PET-TC
This second evaluation will favor the standardization of the interpretation however for reasons of time and opportunity clinical decisions will be made based on the interpretation of the local Nuclear Medicine team
Pre-PET Pre-18F-FDG PET-TC evaluation
Staging
In this phase IFIs will be classified into localized or disseminated disease involvement of more than one non-contiguous organ in the case of fungemia detection of septic metastases and the number of lesions and organs affected will be specified
Prior to the completion of the initial 18F-FDG PET-CT the attending physician will establish a staging and management plan of the IFI based on the data known at that time through a standardized questionnaire need for diagnostic techniques source control including surgical treatment selected drug penetration into involved areas need for combined treatment expected duration of treatment
Response monitoring follow-up
The relevant clinical analytical microbiological and imaging tests performed at the time of the 18F-FDG PET-CT follow-up will be collected Additional tests will be performed according to clinical indication SOC
An evaluation of the response to treatment and management plan of the IFI will be established prior to the performance of the 18F-FDG PET-TC pre-PET including prevision to discontinue or maintain antifungal
Post-PET Post-18F-FDG PET-TC evaluation
Staging
Based on the findings of the 18F-FDG PET-CT IFIs will be classified again in localized or disseminated disease and the number of lesions and organs involved will be specified
The contributions of the 18F-FDG PET-TC to the data that were known prior to its realization will be specifically collected as well as the specific data of the 18F-FDG PET-TC SUV max
Response monitoring -After the PET a re-evaluation of the response to the treatment will be established based on the PET findings and in the first 48 hours after the performance and evaluation of the initial 18F-FDG PET-CT the same responsible physician will reevaluate the management plan based on the findings of the 18F-FDG PET-CT establishing the modifications it deems necessary Clinical decisions will be made based on the interpretation of the local Nuclear Medicine team
The patients outcome will be evaluated at 100 days and 6 months completion of treatment continuation of chemotherapy or performance of stem cell transplantation SCT recurrence survival
Study variables performance clinical impact and evolution according to the objectives
1 Performance variables percentage of patients with IFI in whom 18F-FDG PET-CT has improved patient assessment compared to standard management in
1 Initial staging of infection change in staging localizeddisseminated change in number of organs involved or number of fungal lesions detected number of lesions discordant between pre-PET and post-PET
2 Response to treatment change in the assessment of the IFI response clinical response anatomical response metabolic response
2 Clinical impact variables added value patients benefiting from PET
1 18F-FDG PET-CT will be considered to have added value over SOC when lesions are detected outside the region assessed by other imaging tests 7 clinically hidden lesions dissemination PET reclassifies a radiological finding 8 or leads to the performance of a new targeted diagnostic test
2 When the metabolic information provided by the 18F-FDG PET-CT allows clinical decisions about the patient to be made either to discontinue prolong or change the anti fungal treatment modification of the type of treatment modification of the drug used modification of the duration of treatment or leads to surgical treatment it will be considered to be modification of the treatment and has added value
3 Added value shall be considered when baseline metabolic parameters allow predicting metabolic response to anti fungal therapy
For inclusion in the study two types of IFIs will be considered
IFI in the form of fungemia detection of fungal growth in blood cultures
Focal IFI with tissue invasion patients with a diagnosis of proven or probable IFI according to the corresponding criteria depending on the type of patient Hematology and other immunocompromised European Organization for Research and Treatment of Cancer EORTCMycoses Study Group Education and Research Consortium MS GERC consensus definitions solid organ transplantation 2010 International Society for Heart and Lung Transplantation ISHLT consensus statements for the definitions of infections in cardiothoracic transplant recipients ICUChronic obstructive pulmonary disease Bulpa criteria COVID-19 Coronavirus disease-2019 ECMM European Confederation of Medical MycologyISHAM
Sample size
Based on the literature we assume that 18F-FDG PET-CT will detect lesions not previously visualized in approximately 50 of patients 7 We anticipate that the findings in 50 of these patients will cause the management of IFI to change which corresponds to 25 of the total number of patients To achieve a 6 accuracy in estimating a proportion using a bilateral 95 Normal asymptotic confidence interval assuming that the proportion is 25 it will be necessary to include 201 patients in the study Assuming 10 of abandonments or loss of information it would be necessary to recruit 224 patients
Period of inclusion of patients in the study 2 years Patient Recruitment Upon suspicion of IFI the attending physician will verify that the patient meets all the inclusion criteria and none of the exclusion criteria and will contact Nuclear Medicine to schedule the performance of 18F-FDG PET-CT according to the deadlines established in the study protocol
Intervention
In addition to the usual management detailed below 18F-FDG PET-TC will be performed to evaluate
staging at diagnosis in the first week after diagnosis preferably in the first 48 hours of starting antifungal treatment
response monitoringfollow-up will be carried out on the same equipment as the initial 18F-FDG 18F-2-fluoro-2-deoxy-D-glucose
PET-TC
in the case of fungemia 2 weeks after the initial staging 18F-FDG PET-CT
in the case of focal IFIs 2-4 and 12 weeks after the initial staging 18F-FDG PET-CT
Data collection and analysis The information shall be collected prospectively by means of a data collection notebook eDCN and stored in an anonymized form in a common database specially designed for the study The data will be obtained from the patients medical history of the different participating centers From the database they will be downloaded to the statistical program for analysis which will be carried out with the support of the Biostatistics Unit of Instituto de Investigación Puerta de Hierro-Segovia did Arana IDIPHISA
Demographic clinical variables and results of conventional diagnostic tests including blood count biochemistry cultures according to presentation biomarkers such as galactomannan or D-glucan and imaging tests x-rays CT MRI or echocardiogram performed according to clinical indication standard of care SOC and following the guidelines will be collected Specifically anatomy-based imaging tests will be performed according to the protocols of each department and will be interpreted by certified specialists radiologists echocardiographists etc as appropriate as part of routine care
Analysis of 18F-FDG PET-CT images
In order to standardize the interpretation of the images in the different participating centers a one-day training session will be held before the start of the study with the participation of all the Nuclear Medicine doctors involved in the project
The 18F-FDG PET-CT will be reviewed by the specialist of the patients center who will be blind to the result of the tests performed according to standard of care SOC Additionally the images will be included in the database for evaluation by a second specialist in Nuclear Medicine from the coordinating center blind for the initial interpretation of the 18F-FDG PET-TC
This second evaluation will favor the standardization of the interpretation however for reasons of time and opportunity clinical decisions will be made based on the interpretation of the local Nuclear Medicine team
Pre-PET Pre-18F-FDG PET-TC evaluation
Staging
In this phase IFIs will be classified into localized or disseminated disease involvement of more than one non-contiguous organ in the case of fungemia detection of septic metastases and the number of lesions and organs affected will be specified
Prior to the completion of the initial 18F-FDG PET-CT the attending physician will establish a staging and management plan of the IFI based on the data known at that time through a standardized questionnaire need for diagnostic techniques source control including surgical treatment selected drug penetration into involved areas need for combined treatment expected duration of treatment
Response monitoring follow-up
The relevant clinical analytical microbiological and imaging tests performed at the time of the 18F-FDG PET-CT follow-up will be collected Additional tests will be performed according to clinical indication SOC
An evaluation of the response to treatment and management plan of the IFI will be established prior to the performance of the 18F-FDG PET-TC pre-PET including prevision to discontinue or maintain antifungal
Post-PET Post-18F-FDG PET-TC evaluation
Staging
Based on the findings of the 18F-FDG PET-CT IFIs will be classified again in localized or disseminated disease and the number of lesions and organs involved will be specified
The contributions of the 18F-FDG PET-TC to the data that were known prior to its realization will be specifically collected as well as the specific data of the 18F-FDG PET-TC SUV max
Response monitoring -After the PET a re-evaluation of the response to the treatment will be established based on the PET findings and in the first 48 hours after the performance and evaluation of the initial 18F-FDG PET-CT the same responsible physician will reevaluate the management plan based on the findings of the 18F-FDG PET-CT establishing the modifications it deems necessary Clinical decisions will be made based on the interpretation of the local Nuclear Medicine team
The patients outcome will be evaluated at 100 days and 6 months completion of treatment continuation of chemotherapy or performance of stem cell transplantation SCT recurrence survival
Study variables performance clinical impact and evolution according to the objectives
1 Performance variables percentage of patients with IFI in whom 18F-FDG PET-CT has improved patient assessment compared to standard management in
1 Initial staging of infection change in staging localizeddisseminated change in number of organs involved or number of fungal lesions detected number of lesions discordant between pre-PET and post-PET
2 Response to treatment change in the assessment of the IFI response clinical response anatomical response metabolic response
2 Clinical impact variables added value patients benefiting from PET
1 18F-FDG PET-CT will be considered to have added value over SOC when lesions are detected outside the region assessed by other imaging tests 7 clinically hidden lesions dissemination PET reclassifies a radiological finding 8 or leads to the performance of a new targeted diagnostic test
2 When the metabolic information provided by the 18F-FDG PET-CT allows clinical decisions about the patient to be made either to discontinue prolong or change the anti fungal treatment modification of the type of treatment modification of the drug used modification of the duration of treatment or leads to surgical treatment it will be considered to be modification of the treatment and has added value
3 Added value shall be considered when baseline metabolic parameters allow predicting metabolic response to anti fungal therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None