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NCT02174679 Clinical Trial

68Ga DOTATATE PET/CT in Neuroendocrine Tumors (Expanded Access)

Neuroendocrine Tumors Clinical Trial

Official title:
68Ga-DOTATATE Imaging in Neuroendocrine Tumors

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT02174679
Other study ID # DOTATATE12-001920EA
Secondary ID NCI-2016-01796JC
Status No longer available
Phase
First received
Last updated

Study information
Verified date May 2019
Source Jonsson Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

To evaluate 68Ga-DOTATATE PET/CT for staging of patients with carcinoid, neuroendocrine tumors, medullary thyroid cancer and other cancers expressing somatostatin receptors.

Description:

This is an expanded access study with a total of 300 participants with NET and suspected SSTR positive tumors. Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 68Ga-DOTATATE and will undergo a PET/CT imaging study. All patients referred by Oncologists will be screened by a UCLA Nuclear Medicine physician and then accepted for scanning if clinically appropriate.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Older than 18 years the time of radiotracer administration

- Provides written informed consent

- Known diagnosis of NET or suspected SSTR positive tumors Women of childbearing age must have a negative pregnancy test at screening/baseline

- Able to remain still for duration of each imaging procedure (about 30 minutes)

Exclusion Criteria:

- Less than 18 years-old at the time of radiotracer administration

- Pregnant or nursing

- Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

- Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 68Ga DOTATATE
Patients with somatostatin receptor positive tumors will be evaluated with 68Ga-DOTATATE PET/CT.

Locations
Country Name City State
United States UCLA Hospital Los Angeles California

Sponsors (1)
Lead Sponsor Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

Buchmann I, Henze M, Engelbrecht S, Eisenhut M, Runz A, Schäfer M, Schilling T, Haufe S, Herrmann T, Haberkorn U. Comparison of 68Ga-DOTATOC PET and 111In-DTPAOC (Octreoscan) SPECT in patients with neuroendocrine tumours. Eur J Nucl Med Mol Imaging. 2007 Oct;34(10):1617-26. Epub 2007 May 23. — View Citation

Graham MM, Menda Y. Radiopeptide imaging and therapy in the United States. J Nucl Med. 2011 Dec;52 Suppl 2:56S-63S. doi: 10.2967/jnumed.110.085746. Review. — View Citation

Modlin IM, Kidd M, Hinoue T, Lye KD, Murren J, Argiris A. Molecular strategies and 111in-labelled somatostatin analogues in defining the management of neuroendocrine tumour disease: a new paradigm for surgical management. Surgeon. 2003 Jun;1(3):137-43. — View Citation

Modlin IM, Latich I, Zikusoka M, Kidd M, Eick G, Chan AK. Gastrointestinal carcinoids: the evolution of diagnostic strategies. J Clin Gastroenterol. 2006 Aug;40(7):572-82. Review. — View Citation

Virgolini I, Ambrosini V, Bomanji JB, Baum RP, Fanti S, Gabriel M, Papathanasiou ND, Pepe G, Oyen W, De Cristoforo C, Chiti A. Procedure guidelines for PET/CT tumour imaging with 68Ga-DOTA-conjugated peptides: 68Ga-DOTA-TOC, 68Ga-DOTA-NOC, 68Ga-DOTA-TATE. Eur J Nucl Med Mol Imaging. 2010 Oct;37(10):2004-10. doi: 10.1007/s00259-010-1512-3. — View Citation

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