[68 Ga]-DOTANOC PET/CT in GEP-NETs (GEP-NOC)
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|ClinicalTrials.gov Identifier: NCT02608203|
Recruitment Status : Not yet recruiting
First Posted : November 18, 2015
Last Update Posted : November 18, 2015
Somatostatin receptors are overexpressed in GEP-NETs and can be visualized in vivo by radiolabeled somatostatin-analogs.
During the last decades, conventional scintigraphy using 111In-DTPA-Octreotide (often named somatostatin receptor scintigraphy or SRS) was considered as the gold standard nuclear imaging technique in the evaluation of GEP-NETs. However, SRS may be suboptimal in this clinical setting because of the low intrinsic resolution of the technique and its selectivity for SST2 only. Its overall sensitivity is estimated to 60-70% (per lesion analysis), even when using the most recent SPECT-CT cameras. MRI have also a higher sensitivity than CT and SRS for the detection of liver metastases from GEP-NETs.
In recent years, positron emission tomography (PET) imaging, a high resolution and sensitive technology, has gained an increasing role in oncology. It has also been evaluated in GEP-NETs with somatostatin agonists (SSTa) radiolabelled with Gallium-68 [68Ga], a positron emitter with very promising results. Its diagnostic sensitivity is clearly superior to SRS and many European centers have already replaced SRS by [68Ga]-PET-SSTa.
Currently, three different [68Ga]-coupled peptides can be used in trials: DOTA-TOC, DOTA-TATE and DOTA-NOC with excellent affinities for SST2 (IC50: 2.5; 0.2 and 1.9 nM, respectively). Sensitivities of DOTA-TOC and DOTA-TATE PET/CT are quite similar.
[68Ga]-DOTANOC which also binds to SST5 was recently found to detect significantly more lesions than the SST2-specific radiotracer [68Ga]-DOTATATE in patients with GEP-NETs but this requires further evaluation.
It is therefore important to determine the interest of [68Ga]-DOTANOC combined with the standard diagnosis strategy in GEP-NETs and evaluate medicoeconomic impact of adding [68Ga]-DOTANOC in the work-up of patients.
The investigators hypothesis is that [68Ga]-DOTANOC will modify the management in at least 20% of patients in a more adapted way according to the 2012 ENETS guidelines in comparison to the decision based on the standard imaging work up (multiphasic WB CT, liver MRI and SRS).
110 patients will be included prospectively in 5 different French experienced centers (Marseille, Bordeaux, Toulouse, Paris, Clermond-Ferrand).
|Condition or disease||Intervention/treatment||Phase|
|Gastroenteropancreatic Neuroendocrine Tumors||Drug: [68Ga]-DOTANOC PET/CT||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of [68 Ga]-DOTANOC PET-CT on the Management of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs): Prospective, Multicentric Study.|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
|Experimental: patients with gastroenteropancreatic neuroendocrine tumors||
Drug: [68Ga]-DOTANOC PET/CT
- level of changes (%) between care management before DOTANOC PET and care management after DOTANOC PET [ Time Frame: 6 months ]
- Positive predictive values of DOTANOC PET and standard imaging [ Time Frame: 1 year ]
- negative predictive values of DOTANOC PET and standard imaging [ Time Frame: 1 year ]
- correlation between tumor type and DOTANOC PET results [ Time Frame: 1 year ]
- number of patients for whom PET allowed the detection of lesions not described by standard imaging [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608203
|Contact: David TAIEB, MDfirstname.lastname@example.org|
|AP-HM||Not yet recruiting|
|Contact: David TAIEB, MD email@example.com|
|Study Director:||Urielle Desalbres||AP-HM|