Clinical trial NCT03576040: Whole Body Dynamic 68Ga-DOTATOC PET/CT in Neuroendocrine Tumors
Official title: Prognostic Interest of a Whole Body Dynamic PET Acquisition in Pre-therapeutic 68Ga-DOTATOC PET/CT for Neuroendocrine Tumors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuroendocrine Tumors
Keywords: Positron Emission Tomography Computed Tomography
whole body dynamic acquisition
Gallium 68
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-07-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with NET histologically proven and presented in RCP RENATEN at CHRU Brest Primitive: Gastroenteropancreatic, bronchopulmonary or unknown

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


Eligibility criteria: Inclusion Criteria:

* Patient majeur ≥ 18 year old
* Présenting a well differentiated neuroendocrine tumor (G1 ou G2)
* Indication performing a68Ga-DOTATOC PET/CT
* non-opposition

Exclusion Criteria:

* Patient \<18 years old
* Breastfeeding/ pregnancy
* Other type of tumor
* Refusal of participation

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 2 years
measure: Recidive free survival (RFS)
timeFrame: 2 years
Secondary outcomes:
measure: Correlation between lesionnal Ki and immunochemistry markers
timeFrame: 0 to 2 years
measure: Predictive value of non-event survival (PFS+RFS)
timeFrame: 6 months to 2 years
measure: Correlation between 68Ga-DOTATOC PET/CT and/or 111In-pentetréotide SPECT/CT and 177Lu-DOTATATE SPECT/CT
timeFrame: 0 to 2 years
measure: Prognostic value of Ki versus usual prognostic parameters
timeFrame: 2 years
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References: