Ignite Creation Date:
2024-05-06 @ 3:47 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02372890
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2015-01-19
Brief Title:
Validation of High-resolution PETCT for the Pretherapeutic Lymphnode Staging of HeadNeck Cancer
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Validation of High-resolution PETCT for the Pretherapeutic Lymphnode Staging of HeadNeck Cancer
Status:
COMPLETED
Status Verified Date:
2019-02
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:
In head and neck squamous cell carcinoma HNSCC the presence of lymph node metastases in addition to free resection margins following surgical resection of the primary tumor is an important prognostic factor and may impact planning of surgery as well as of radiotherapy Until now imaging modalities including PETCT and MRI did not allow to exclude especially small lymph node metastases
Compared to standard whole-body PETCT acquisition techniques high-resolution HR head and neck PETCT acquisitions promise improved detection of lymph node metastases in head and neck squamous cell carcinoma HNSCC This prospective study aims to determine the sensitivity and specificity of lymph node staging with HR FDG-PETCT in HNSCC by correlating PETCT with histopathology after neck dissection HR PETCT may have a relevant impact on the therapeutic concept and the planning and dose prescription of radiotherapy
Compared to standard whole-body PETCT acquisition techniques high-resolution HR head and neck PETCT acquisitions promise improved detection of lymph node metastases in head and neck squamous cell carcinoma HNSCC This prospective study aims to determine the sensitivity and specificity of lymph node staging with HR FDG-PETCT in HNSCC by correlating PETCT with histopathology after neck dissection HR PETCT may have a relevant impact on the therapeutic concept and the planning and dose prescription of radiotherapy
Detailed Description:
In head and neck squamous cell carcinoma HNSCC the presence of lymph node metastases in addition to free resection margins following surgical resection of the primary tumor is an important prognostic factor and may impact planning of surgery as well as of radiotherapy Neck dissection and histopathology are regarded as diagnostic standard procedures to define the lymph node status in patients with HNSCC Occult lymph node metastases after imaging have been described in up to 46 of patients eg in patients with cancer of the tongue
Although neck dissection generally has a low rate of intra- and postoperative complications a small but statistically significant group of patients suffers from surgery-related side effects such as lymphedema chronic pain syndromes and injury of cranial nerves with paralysis shoulder lift and mouth angle Therefore it would be desirable to spare diagnostic neck dissection in patients without macroscopic lymph node metastasis However the sensitivity andor specificity of the non-invasive imaging techniques available up to now including positron emission tomography PET and magnetic resonance imaging MRI did not allow to exclude lymph node metastases which is especially true for small metastases Therefore imaging is not able to replace the histological examination of the cervical lymph nodes and have limited impact on the therapeutic concept the surgical planning and the planning and dose prescription of radiotherapy
Acquisition techniques and image quality of PET with the glucose analog F-18-fluorodeoxyglucose FDG and the combined examination with computed tomography PETCT were considerably improved with last generation PETCT machines New generation PETCT machines provide significantly improved image quality and image resolution image and probably higher sensitivity to detect smaller lesions However in the face of an expected increase of detected metabolically active cervical lymph nodes by high-resolution HR PETCT a diagnostic problem in terms of a potentially increased number of false-positive lymph nodes arises e g due to an inflammatory lymphadenopathy
Until now there are no evidence-based criteria to classify small metabolically active lymph nodes detected by HR PETCT Hence a correlation of PETCT findings and histopathology of cervical lymph metastases and inflammatory lymph nodes in patients with HNSCC is required to develop diagnostic criteria for HR PETCT and to exploit the diagnostic potential of HR PETCT
Modern concepts of radiotherapy planning for neck lymph node metastases increasingly take into consideration the metabolic and morphological information of PETCT for target volume definition Detailed information on the diagnostic performance of HR PET CT are of importance for the dose prescription of intensity-modulated radiotherapy IMRT In radiotherapy side effects depend significantly on the dose and the irradiation volume Modern radiation techniques especially IMRT allow for highly-conformal radiation therapy with steep dose gradients to protect organs such as the salivary glands and to reduce side effects of radiotherapy On the other hand modern radiotherapy concepts carry the risk to fail due to non-inclusion of subclinical lymph node metastases in the target volume HR PETCT may allow to minimize out-of-field recurrences caused by incorrect target volume contouring or dose prescription Evidence-based data on the diagnostic accuracy of HR PETCT with special regard to small lymph node metastases are needed to clarify the potential role of HR PETCT for radiation treatment planning
Objective
To determine the sensitivity specificity accuracy PPV and NPV of lymph node staging with HR PETCT in patients with HNSCC
To determine the sensitivity specificity accuracy PPV and NPV of HR PETCT for lymph node metastases of different size in patients with HNSCC
To determine the detection rate of distant metastases by PETCT in patients with HNSCC
To develop diagnostic criteria for the multi-modal lymph node staging with HR PETCT in patients with HNSCC
To evaluate the potential impact of HR PETCT on radiation treatment planning
Methods
Patients with HNSCC are managed according to clinical recommendations of the interdisciplinary tumor board Elective patients receive selective modified radical or radical neck dissection of the relevant lymph node region according to clinical routine standards at the Inselspital Bern The neck dissection must be carried out within a maximum of 6 weeks after the PET CT examination
As part of the neck dissection the lymph nodes will be sent to the Institute of Pathology separated by level and side by topographic markers cranial caudal medial lateral The histological examination of the removed lymph nodes serves as reference standard for the analysis of PETCT image data and calculation of the diagnostic accuracy of HR PETCT
Theoretical radiation treatment plans are generated based on conventional imaging whole-body PETCT and HR PETCT protocols to determine the impact of PETCT
Although neck dissection generally has a low rate of intra- and postoperative complications a small but statistically significant group of patients suffers from surgery-related side effects such as lymphedema chronic pain syndromes and injury of cranial nerves with paralysis shoulder lift and mouth angle Therefore it would be desirable to spare diagnostic neck dissection in patients without macroscopic lymph node metastasis However the sensitivity andor specificity of the non-invasive imaging techniques available up to now including positron emission tomography PET and magnetic resonance imaging MRI did not allow to exclude lymph node metastases which is especially true for small metastases Therefore imaging is not able to replace the histological examination of the cervical lymph nodes and have limited impact on the therapeutic concept the surgical planning and the planning and dose prescription of radiotherapy
Acquisition techniques and image quality of PET with the glucose analog F-18-fluorodeoxyglucose FDG and the combined examination with computed tomography PETCT were considerably improved with last generation PETCT machines New generation PETCT machines provide significantly improved image quality and image resolution image and probably higher sensitivity to detect smaller lesions However in the face of an expected increase of detected metabolically active cervical lymph nodes by high-resolution HR PETCT a diagnostic problem in terms of a potentially increased number of false-positive lymph nodes arises e g due to an inflammatory lymphadenopathy
Until now there are no evidence-based criteria to classify small metabolically active lymph nodes detected by HR PETCT Hence a correlation of PETCT findings and histopathology of cervical lymph metastases and inflammatory lymph nodes in patients with HNSCC is required to develop diagnostic criteria for HR PETCT and to exploit the diagnostic potential of HR PETCT
Modern concepts of radiotherapy planning for neck lymph node metastases increasingly take into consideration the metabolic and morphological information of PETCT for target volume definition Detailed information on the diagnostic performance of HR PET CT are of importance for the dose prescription of intensity-modulated radiotherapy IMRT In radiotherapy side effects depend significantly on the dose and the irradiation volume Modern radiation techniques especially IMRT allow for highly-conformal radiation therapy with steep dose gradients to protect organs such as the salivary glands and to reduce side effects of radiotherapy On the other hand modern radiotherapy concepts carry the risk to fail due to non-inclusion of subclinical lymph node metastases in the target volume HR PETCT may allow to minimize out-of-field recurrences caused by incorrect target volume contouring or dose prescription Evidence-based data on the diagnostic accuracy of HR PETCT with special regard to small lymph node metastases are needed to clarify the potential role of HR PETCT for radiation treatment planning
Objective
To determine the sensitivity specificity accuracy PPV and NPV of lymph node staging with HR PETCT in patients with HNSCC
To determine the sensitivity specificity accuracy PPV and NPV of HR PETCT for lymph node metastases of different size in patients with HNSCC
To determine the detection rate of distant metastases by PETCT in patients with HNSCC
To develop diagnostic criteria for the multi-modal lymph node staging with HR PETCT in patients with HNSCC
To evaluate the potential impact of HR PETCT on radiation treatment planning
Methods
Patients with HNSCC are managed according to clinical recommendations of the interdisciplinary tumor board Elective patients receive selective modified radical or radical neck dissection of the relevant lymph node region according to clinical routine standards at the Inselspital Bern The neck dissection must be carried out within a maximum of 6 weeks after the PET CT examination
As part of the neck dissection the lymph nodes will be sent to the Institute of Pathology separated by level and side by topographic markers cranial caudal medial lateral The histological examination of the removed lymph nodes serves as reference standard for the analysis of PETCT image data and calculation of the diagnostic accuracy of HR PETCT
Theoretical radiation treatment plans are generated based on conventional imaging whole-body PETCT and HR PETCT protocols to determine the impact of PETCT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None