Whole Body Dynamic 68Ga-DOTATOC PET/CT in Neuroendocrine Tumors
- Conditions
- Neuroendocrine Tumors
- Registration Number
- NCT03576040
- Lead Sponsor
- University Hospital, Brest
- Brief Summary
Neuroendocrine tumors (NET) are a network of rare tumors with common embryological origin. Functional imaging plays a major role in the extension assessment and tumor characterization of NETs. SPECT/CT with 111In-pentetreotide is the recommended test when tumors are well differentiated (grade G1 or G2). It has a real interest in diagnosis, in therapeutic decision-making (in particular by cold somatostatin analogues or in PRRT) and in the systematic follow-up of patients. Nevertheless, SPECT/CT procedure makes for a relatively long review. In addition, scintigraphy has a lower spatial resolution than PET technology and remains of limited interest for signal quantification.
However, the ability to locate and quantitatively measure the absorption of radiopharmaceuticals in the target tissues is a major challenge in oncology for the characterization of the disease.
Recent developments in radiopharmacy have made it possible to target NETs in PET imaging through the use of somatostatin analogues coupled with positron emitters, called 68Ga-DOTA peptides. The diagnostic performance of 68Ga-DOTApeptide PET/CT appears to be superior to SPECT/CT with 111In-pentetreotide. A marketing authorization has thus recently been issued in France for the use of 68Ga-DOTATOC.
Historically, the recommended quantification method in PET was based on the instantaneous measurement in static acquisition (3D) of the maximum of the standardized uptake value (SUVmax). This approach has the disadvantage to measure the signal at a time "t" for a single voxel of the image. Dynamic acquisition methods (4D) have been proposed to extract a radiotracer absorption coefficient (Ki) for a lesion. Several studies have demonstrated the superiority of Ki versus SUVmax in 18FDG PET/CT for the diagnostic management, therapeutic evaluation and prognosis of various solid cancers.
However, no work has validated this approach in PET / CT at 68Ga-DOTATOC as part of the prognostic evaluation of NETs.
The objective of the study is to evaluate the prognostic value of the tumor absorption coefficient Ki resulting from a 4D whole-body dynamic acquisition in PET / CT at 68Ga-DOTATOC in patients with well-differentiated NETs grade I or II according to the WHO classification
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- Patient majeur ≥ 18 year old
- Présenting a well differentiated neuroendocrine tumor (G1 ou G2)
- Indication performing a68Ga-DOTATOC PET/CT
- non-opposition
- Patient <18 years old
- Breastfeeding/ pregnancy
- Other type of tumor
- Refusal of participation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recidive free survival (RFS) 2 years To evaluate the prognostic value of Ki lesion on progression-free survival at 2 years and compare it with SUVmax (static 3D acquisition) in patients with localised well-differentiated NET
Progression free survival (PFS) 2 years To evaluate the prognostic value of lesionnal Ki on progression-free survival at 2 years and compare it with SUVmax (static 3D acquisition) in patients with metastatic well-differentiated NET
- Secondary Outcome Measures
Name Time Method Predictive value of non-event survival (PFS+RFS) 6 months to 2 years To evaluate the predictive value of non-event survival (PFS+RFS) with a ΔKi approach in patients receiving an intermediate therapeutic assessment examination (somatostatin analogues or PRRT with 177Lu-DOTATATE), and compare it with a ΔSUVmax approach
Correlation between 68Ga-DOTATOC PET/CT and/or 111In-pentetréotide SPECT/CT and 177Lu-DOTATATE SPECT/CT 0 to 2 years Evaluate the statistical correlation between the SUVmax assessed with 68Ga-DOTATOC PET/CT and/or 111In-pentetréotide SPECT/CT and 177Lu-DOTATATE SPECT/CT
Correlation between lesionnal Ki and immunochemistry markers 0 to 2 years Evaluate the statistical correlation between lesional Ki versus SUVmax with NET immunohistochemistry markers expression (SSTR2, SSTR3, and SSTR5; BCL2, Phospho-MTOR expression PD-L1 by tumor cells and immune cells, intra-tumor CD8 + lymphocytes, tumor necrosis surface)
Prognostic value of Ki versus usual prognostic parameters 2 years To evaluate the prognostic value on non-event survival (PFS+RFS) at 2 years of Ki and clinical parameters (sex, age), biological (CgA assay), pathology (grade, differentiation, Ki67 expression, BCL2, phospho-MTOR).
Trial Locations
- Locations (1)
CHRU de Brest
🇫🇷Brest, France