Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06103838
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-10-26
Brief Title:
18F-Fluciclovine PETCT in Multiple Myeloma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Trial Evaluating 18F-Fluciclovine PETCT in Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-09-26
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:
None
Brief Summary:
Background
Multiple myeloma MM is an incurable cancer of certain blood cells MM often returns after treatment and most people survive only 5 to 8 years after diagnosis To improve survival researchers need to find ways to identify returning disease earlier
Objective
To find out if the radiotracer 18F-fluciclovine a substance injected into the blood during imaging scans is better at detecting MM than the one 18F-FDG currently used for this purpose
Eligibility
Adults aged 18 years or older with MM The MM may be newly diagnosed NDMM or it may have returned or failed to respond after at least 1 prior line of treatment RRMM
Design
Participants will be screened They will have blood tests They will have a positron emission tomography PET or computed tomography CT scan using 18F-FDG The radiotracer will be injected into a vein Then participants will lie on a table while the PETCT scan takes images of their body
All participants will have 3 study visits During each visit they will have
Two PETCT scans One with 18F-FDG one with 18F-fluciclovine
An optional magnetic resonance imaging scan
A bone marrow biopsy An area on the hip will be numbed a needle will be inserted to draw out a sample of the soft tissue from inside the bone
These tests may be spread over 30 days for each visit
NDMM participants will have their second study visit 2 to 4 weeks after they complete their usual treatment for the disease RRMM participants will have their second visit 6 months after their first
All participants will have a third study visit after 5 years or when their disease progresses
Multiple myeloma MM is an incurable cancer of certain blood cells MM often returns after treatment and most people survive only 5 to 8 years after diagnosis To improve survival researchers need to find ways to identify returning disease earlier
Objective
To find out if the radiotracer 18F-fluciclovine a substance injected into the blood during imaging scans is better at detecting MM than the one 18F-FDG currently used for this purpose
Eligibility
Adults aged 18 years or older with MM The MM may be newly diagnosed NDMM or it may have returned or failed to respond after at least 1 prior line of treatment RRMM
Design
Participants will be screened They will have blood tests They will have a positron emission tomography PET or computed tomography CT scan using 18F-FDG The radiotracer will be injected into a vein Then participants will lie on a table while the PETCT scan takes images of their body
All participants will have 3 study visits During each visit they will have
Two PETCT scans One with 18F-FDG one with 18F-fluciclovine
An optional magnetic resonance imaging scan
A bone marrow biopsy An area on the hip will be numbed a needle will be inserted to draw out a sample of the soft tissue from inside the bone
These tests may be spread over 30 days for each visit
NDMM participants will have their second study visit 2 to 4 weeks after they complete their usual treatment for the disease RRMM participants will have their second visit 6 months after their first
All participants will have a third study visit after 5 years or when their disease progresses
Detailed Description:
Background
Multiple myeloma MM is an incurable malignancy of plasma cells that leads to destructive bone lesions renal damage anemia and hypercalcemia MM is the second most common hematologic malignancy The American Cancer Society estimates that annually over 34000 new cases of MM will occur in the US and over 12000 deaths due to MM in 2022
Overall survival OS has improved significantly over the past 20 years with the development of proteasome inhibitors PIs immunomodulatory agents IMiDs and anti-CD38 monoclonal antibodies However despite these advances patients ultimately relapse requiring multiple subsequent lines of therapy As MM evolves it generally becomes more refractory and patients ultimately succumb to their disease
With multiple lines of efficacious therapies the correct early identification of relapsed disease is important to trigger initiation of a new line of therapy
Limitations in conventional imaging highlight a need for molecular imaging agents with better sensitivity for detecting and measuring tumor burden to improve staging and treatment selection for patients with MM and plasma cell dyscrasias
18F-fluciclovine is a radionuclide approved by the FDA for evaluating suspected prostate cancer recurrence but has shown additional ability in detecting MM lesions
Objective
To determine the concordance between 18F-fluciclovine PETCT and 18F-FDG PETCT in participants with multiple myeloma
Eligibility
Participants 18 years old
Eastern Cooperative Oncology Group ECOG Performance score of 0 to 2
Participants must have a documented diagnosis of MM defined by the International Myeloma Working Group IMWG Criteria
Participants fit criteria for one of the following categories
Newly diagnosed multiple myeloma NDMM without previous treatment or within the first 3 cycles of front-line treatment
Relapsed andor Refractory multiple myeloma RRMM with at least 1 prior line of therapy
Design
This is an open-label single center phase 2 study evaluating 18F-fluciclovine PETCT imaging in up to 50 participants with multiple myeloma Participants will be enrolled into one of two cohorts based on disease status newly diagnosed multiple myeloma NDMM participants will be enrolled into Cohort 1 and relapsed refractory multiple myeloma RRMM participants will be enrolled into Cohort 2 All subjects will undergo an 18F-fluciclovine injection followed by a static whole-body PETCT at three time points Timepoint 1 Timepoint 2 after induction for NDMM or at 6 months for RRMM and Timepoint 3 at progression or at 5 years Results will be compared to 18F-FDG PETCT imaging at those same timepoints
Multiple myeloma MM is an incurable malignancy of plasma cells that leads to destructive bone lesions renal damage anemia and hypercalcemia MM is the second most common hematologic malignancy The American Cancer Society estimates that annually over 34000 new cases of MM will occur in the US and over 12000 deaths due to MM in 2022
Overall survival OS has improved significantly over the past 20 years with the development of proteasome inhibitors PIs immunomodulatory agents IMiDs and anti-CD38 monoclonal antibodies However despite these advances patients ultimately relapse requiring multiple subsequent lines of therapy As MM evolves it generally becomes more refractory and patients ultimately succumb to their disease
With multiple lines of efficacious therapies the correct early identification of relapsed disease is important to trigger initiation of a new line of therapy
Limitations in conventional imaging highlight a need for molecular imaging agents with better sensitivity for detecting and measuring tumor burden to improve staging and treatment selection for patients with MM and plasma cell dyscrasias
18F-fluciclovine is a radionuclide approved by the FDA for evaluating suspected prostate cancer recurrence but has shown additional ability in detecting MM lesions
Objective
To determine the concordance between 18F-fluciclovine PETCT and 18F-FDG PETCT in participants with multiple myeloma
Eligibility
Participants 18 years old
Eastern Cooperative Oncology Group ECOG Performance score of 0 to 2
Participants must have a documented diagnosis of MM defined by the International Myeloma Working Group IMWG Criteria
Participants fit criteria for one of the following categories
Newly diagnosed multiple myeloma NDMM without previous treatment or within the first 3 cycles of front-line treatment
Relapsed andor Refractory multiple myeloma RRMM with at least 1 prior line of therapy
Design
This is an open-label single center phase 2 study evaluating 18F-fluciclovine PETCT imaging in up to 50 participants with multiple myeloma Participants will be enrolled into one of two cohorts based on disease status newly diagnosed multiple myeloma NDMM participants will be enrolled into Cohort 1 and relapsed refractory multiple myeloma RRMM participants will be enrolled into Cohort 2 All subjects will undergo an 18F-fluciclovine injection followed by a static whole-body PETCT at three time points Timepoint 1 Timepoint 2 after induction for NDMM or at 6 months for RRMM and Timepoint 3 at progression or at 5 years Results will be compared to 18F-FDG PETCT imaging at those same timepoints
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 001525-C | None | None | None |