drugset / Trial / NCT02078843
Diagnostic Accuracy of Gallium-68-DOTATATE PET/CT Compared to Indium-111-pentetreotide Scintigraphy (SPECT/CT) for Gastroenteropancreatic Neuroendocrine Tumors
Phase 1/2
Terminated
54 enrolled
Insel Gruppe AG, University Hospital Bern
SWAN Isotopen AG, Bern · collabUniversity Hospital, Basel, Switzerland · collabUniversity of Bern · collabUniversity of Lausanne Hospitals · collab
NaSingle-groupOpen-labelDiagnostic
Summary
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.
Timeline
- Start
- 2014-03
- Primary completion
- 2016-08
- Completion
- 2016-08
Publications
- Background Gabriel 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.
- Background Putzer 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.
- Background Antunes 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.
- Background Reubi 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.
- Background Srirajaskanthan 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 68Ga-DOTATATE | Diagnostic / imaging agent | — | — |
| Subject | Indium-111-Octreoscan (standard test) | Unknown | — | — |