Validation of 99mTc- EDDA - HYNIC -TOC Kits for Diagnosis of Neuroendocrine Tumors
Sponsor
Latin American Cooperative Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT02691078
Collaborator
Financiadora de Estudos e Projetos (Other), Instituto do Cérebro do Rio Grande do Sul - InsCer (Other)
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Study Details
Study Description
Brief Summary
Evaluation of the properties of the image capture test using 99m Tc - HYNIC -TOC EDDA (octreotide labeled with 99mTc) for the diagnosis of neuroendocrine tumors compared to the 111In - DTPA-octreotide.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Validation of 99mTc- EDDA - HYNIC -TOC Kits for Diagnosis of Neuroendocrine Tumors
Study Start Date
:
Jul 1, 2016
Actual Primary Completion Date
:
Jan 1, 2018
Actual Study Completion Date
:
Jan 10, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Adult patients with neuroendocrine tumors
|
Other: 99m Tc - HYNIC -TOC EDDA and 111In - DTPA-octreotide
The patient will undercome an PET/CT exam with 99m Tc - HYNIC -TOC EDDA, after 20 days of wash out, the same patient will undercome the same exam with 111In - DTPA-octreotide in order to compare both radiopharmaceuticals
|
Outcome Measures
Primary Outcome Measures
- Analysis of the images captured with 99m Tc - HYNIC -TOC EDDA ( octreotide labeled with 99mTc ) and 111In - DTPA-octreotide for the diagnosis of neurocrine tumors [Up to 30 days]
Secondary Outcome Measures
- Visualization of the ocurrence of the neuroendocrine tumor lesions with both radiopharmaceutical agents [Up to 30 days]
- Number of neuroendocrine tumor lesions visualized with both radiopharmaceutical agents [Up to 30 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients with histological diagnosis of neuroendocrine tumors
-
Patients with indication for the staging exam with 11In
-
Patients diagnosed in any tumor stage
-
Patients with > 18 years
-
Male and female patients
-
Patients not receiving somatostatin analogues for at least 1 month before image capturing
Exclusion Criteria:
-
Pregnant women
-
Patients with previous tumor resection of the primary tumor without metastatic disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Instituto do Cérebro do Rio Grande do Sul | Porto Alegre | Rio Grande Do Sul | Brazil |
Sponsors and Collaborators
- Latin American Cooperative Oncology Group
- Financiadora de Estudos e Projetos
- Instituto do Cérebro do Rio Grande do Sul - InsCer
Investigators
- Study Director: Gustavo Werutsky, MD, Latin American Cooperative Oncology Group
Study Documents (Full-Text)
None provided.More Information
Publications
- Bangard M, Béhé M, Guhlke S, Otte R, Bender H, Maecke HR, Biersack HJ. Detection of somatostatin receptor-positive tumours using the new 99mTc-tricine-HYNIC-D-Phe1-Tyr3-octreotide: first results in patients and comparison with 111In-DTPA-D-Phe1-octreotide. Eur J Nucl Med. 2000 Jun;27(6):628-37.
- Decristoforo C, Mather SJ, Cholewinski W, Donnemiller E, Riccabona G, Moncayo R. 99mTc-EDDA/HYNIC-TOC: a new 99mTc-labelled radiopharmaceutical for imaging somatostatin receptor-positive tumours; first clinical results and intra-patient comparison with 111In-labelled octreotide derivatives. Eur J Nucl Med. 2000 Sep;27(9):1318-25.
- Dierdorf SF. Carcinoid tumor and carcinoid syndrome. Curr Opin Anaesthesiol. 2003 Jun;16(3):343-7.
- Frilling A, Akerström G, Falconi M, Pavel M, Ramos J, Kidd M, Modlin IM. Neuroendocrine tumor disease: an evolving landscape. Endocr Relat Cancer. 2012 Sep 14;19(5):R163-85. doi: 10.1530/ERC-12-0024. Print 2012 Oct. Review.
- Gabriel M, Decristoforo C, Donnemiller E, Ulmer H, Watfah Rychlinski C, Mather SJ, Moncayo R. An intrapatient comparison of 99mTc-EDDA/HYNIC-TOC with 111In-DTPA-octreotide for diagnosis of somatostatin receptor-expressing tumors. J Nucl Med. 2003 May;44(5):708-16.
- Hodgson N, Koniaris LG, Livingstone AS, Franceschi D. Gastric carcinoids: a temporal increase with proton pump introduction. Surg Endosc. 2005 Dec;19(12):1610-2. Epub 2005 Oct 5.
- Jones SR, Carley S, Harrison M. An introduction to power and sample size estimation. Emerg Med J. 2003 Sep;20(5):453-8. Review. Erratum in: Emerg Med J. 2004 Jan;21(1):126.
- Kaltsas G, Rockall A, Papadogias D, Reznek R, Grossman AB. Recent advances in radiological and radionuclide imaging and therapy of neuroendocrine tumours. Eur J Endocrinol. 2004 Jul;151(1):15-27. Review.
- Kaltsas GA, Besser GM, Grossman AB. The diagnosis and medical management of advanced neuroendocrine tumors. Endocr Rev. 2004 Jun;25(3):458-511. Review.
- Krenning EP, Kwekkeboom DJ, Bakker WH, Breeman WA, Kooij PP, Oei HY, van Hagen M, Postema PT, de Jong M, Reubi JC, et al. Somatostatin receptor scintigraphy with [111In-DTPA-D-Phe1]- and [123I-Tyr3]-octreotide: the Rotterdam experience with more than 1000 patients. Eur J Nucl Med. 1993 Aug;20(8):716-31. Review.
- Lamberts SW, Hofland LJ, de Herder WW, Kwekkeboom DJ, Reubi JC, Krenning EP. Octreotide and related somatostatin analogs in the diagnosis and treatment of pituitary disease and somatostatin receptor scintigraphy. Front Neuroendocrinol. 1993 Jan;14(1):27-55. Review.
- Lamberts SW, Reubi JC, Krenning EP. Validation of somatostatin receptor scintigraphy in the localization of neuroendocrine tumors. Acta Oncol. 1993;32(2):167-70. Review.
- Mocellin S, Nitti D. Gastrointestinal carcinoid: epidemiological and survival evidence from a large population-based study (n = 25 531). Ann Oncol. 2013 Dec;24(12):3040-4. doi: 10.1093/annonc/mdt377. Epub 2013 Sep 19.
- Modlin IM, Kidd M, Latich I, Zikusoka MN, Shapiro MD. Current status of gastrointestinal carcinoids. Gastroenterology. 2005 May;128(6):1717-51. Review.
- Moran CA, Suster S. Neuroendocrine carcinomas (carcinoid, atypical carcinoid, small cell carcinoma, and large cell neuroendocrine carcinoma): current concepts. Hematol Oncol Clin North Am. 2007 Jun;21(3):395-407; vii. Review.
- Öberg K. Gallium-68 somatostatin receptor PET/CT: is it time to replace (111)Indium DTPA octreotide for patients with neuroendocrine tumors? Endocrine. 2012 Aug;42(1):3-4. doi: 10.1007/s12020-012-9681-4.
- Pinchot SN, Holen K, Sippel RS, Chen H. Carcinoid tumors. Oncologist. 2008 Dec;13(12):1255-69. doi: 10.1634/theoncologist.2008-0207. Epub 2008 Dec 17. Review.
- Reubi JC, Waser B, Schaer JC, Laissue JA. Somatostatin receptor sst1-sst5 expression in normal and neoplastic human tissues using receptor autoradiography with subtype-selective ligands. Eur J Nucl Med. 2001 Jul;28(7):836-46. Erratum in: Eur J Nucl Med 2001 Sep;28(9):1433.
- Rufini V, Calcagni ML, Baum RP. Imaging of neuroendocrine tumors. Semin Nucl Med. 2006 Jul;36(3):228-47. Review.
- Rust E, Hubele F, Marzano E, Goichot B, Pessaux P, Kurtz JE, Imperiale A. Nuclear medicine imaging of gastro-entero-pancreatic neuroendocrine tumors. The key role of cellular differentiation and tumor grade: from theory to clinical practice. Cancer Imaging. 2012 May 21;12:173-84. doi: 10.1102/1470-7330.2012.0026. Review.
- Silberstein EB, Ryan J. Prevalence of adverse reactions in nuclear medicine. Pharmacopeia Committee of the Society of Nuclear Medicine. J Nucl Med. 1996 Jan;37(1):185-92. Erratum in: J Nucl Med 1996 Jun;37(6):1064-7.
- Sundin A, Garske U, Orlefors H. Nuclear imaging of neuroendocrine tumours. Best Pract Res Clin Endocrinol Metab. 2007 Mar;21(1):69-85. Review.
- Vallabhajosula, S. Molecular Imaging: radiopharmaceuticals for PET and SPECT. New York: Springer, 2009. 371p
Responsible Party:
Latin American Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT02691078
Other Study ID Numbers:
- LACOG 0214
First Posted:
Feb 25, 2016
Last Update Posted:
Oct 5, 2020
Last Verified:
Oct 1, 2020