Clinical trial · Interventional
Diagnostic Accuracy of Gallium-68-DOTATATE PET/CT Compared to Indium-111-pentetreotide Scintigraphy (SPECT/CT) for Gastroenteropancreatic Neuroendocrine Tumors
NCT02078843CI-TRIAL-00023785GaINterminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Superiority of one imaging method
Summary
Brief summary (as posted)
The investigators hypothesize that the new imaging method Gallium-68-DOTATATE has a higher diagnostic value in the detection of neuroendocrine tumors than the established imaging method Indium-111-Octreoscan. Therefore, the investigators will perform both imaging procedures in patients with suspected or confirmed neuroendocrine tumors. Subsequently, the investigators will compare the diagnostic performance of both methods.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastroenteropancreatic Neuroendocrine Tumors | Digestive System Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gallium-68-DOTATATE PET/CT (index test) | Drug | — | UNRESOLVED |
| Indium-111-Octreoscan (standard test) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- All patients
- description
- Subsequent performance of index test and standard test
- interventionNames
- Drug: Gallium-68-DOTATATE PET/CT (index test)
- Drug: Indium-111-Octreoscan (standard test)
Primary outcomes (2)
- measure
- Number of patients correctly identified as having GEP-NET by using Gallium-68-DOTATATE PET/CT and Indium-111-pentetreotide scintigraphy (SPECT/CT)
- timeFrame
- 6 months
- measure
- Number of patients correctly identified as not having GEP-NET by using Gallium-68-DOTATATE PET/CT and Indium-111-pentetreotide scintigraphy (SPECT/CT)
- timeFrame
- 6 months
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Signed written informed consent with full understanding of the study procedures and the investigational nature of the study * Patient referred to Indium-111-pentetreotide scintigraphy., which was performed as part of clinical routine care * Inclusion criteria specific for cases only * Histologically established GEP-NET (new or recurrent) * Tumor mass remaining after initial biopsy or surgery * Inclusion criteria specific for controls only * 5.6. Suspicion of any NET (new or recurrent) but no established diagnosis or established diagnosis of any NET (new or recurrent) but no remaining tumor mass after surgery Exclusion Criteria * Previous inclusion in the same study with the following exception: a patient may be included as case if she/he was previously included as control * Gastric type 2 ECL cell neuroendocrine tumors * Pregnant or nursing women * Known intolerance to any protocol required diagnostic intervention * Patient's lack of accountability, inability to appreciate the nature, meaning and consequences of the study and to formulate his/her own wishes correspondingly * Exclusion criteria specific for controls only * Patients for whom it remains unclear whether the tumor was completely removed
References
Publications (5)
- BACKGROUNDGabriel M, Oberauer A, Dobrozemsky G, Decristoforo C, Putzer D, Kendler D, Uprimny C, Kovacs P, Bale R, Virgolini IJ. 68Ga-DOTA-Tyr3-octreotide PET for assessing response to somatostatin-receptor-mediated radionuclide therapy. J Nucl Med. 2009 Sep;50(9):1427-34. doi: 10.2967/jnumed.108.053421. Epub 2009 Aug 18. PMID 19690033
- BACKGROUNDPutzer D, Gabriel M, Henninger B, Kendler D, Uprimny C, Dobrozemsky G, Decristoforo C, Bale RJ, Jaschke W, Virgolini IJ. Bone metastases in patients with neuroendocrine tumor: 68Ga-DOTA-Tyr3-octreotide PET in comparison to CT and bone scintigraphy. J Nucl Med. 2009 Aug;50(8):1214-21. doi: 10.2967/jnumed.108.060236. Epub 2009 Jul 17. PMID 19617343
- BACKGROUNDAntunes P, Ginj M, Zhang H, Waser B, Baum RP, Reubi JC, Maecke H. Are radiogallium-labelled DOTA-conjugated somatostatin analogues superior to those labelled with other radiometals? Eur J Nucl Med Mol Imaging. 2007 Jul;34(7):982-93. doi: 10.1007/s00259-006-0317-x. Epub 2007 Jan 16. PMID 17225119
- BACKGROUNDReubi JC, Schar JC, Waser B, Wenger S, Heppeler A, Schmitt JS, Macke HR. Affinity profiles for human somatostatin receptor subtypes SST1-SST5 of somatostatin radiotracers selected for scintigraphic and radiotherapeutic use. Eur J Nucl Med. 2000 Mar;27(3):273-82. doi: 10.1007/s002590050034. PMID 10774879
- BACKGROUNDSrirajaskanthan R, Kayani I, Quigley AM, Soh J, Caplin ME, Bomanji J. The role of 68Ga-DOTATATE PET in patients with neuroendocrine tumors and negative or equivocal findings on 111In-DTPA-octreotide scintigraphy. J Nucl Med. 2010 Jun;51(6):875-82. doi: 10.2967/jnumed.109.066134. Epub 2010 May 19. PMID 20484441