Clinical trial NCT02174679: 68Ga DOTATATE PET/CT in Neuroendocrine Tumors (Expanded Access)
Official title: 68Ga-DOTATATE Imaging in Neuroendocrine Tumors
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Carcinoid Cancer
Neuroendocrine Tumors
Medullary Thyroid Cancer
Cancers Expressing Somatostatin Receptors
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-06-25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Hospital
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Johannes Czernin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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. doi: 10.1097/00004836-200608000-00003.
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.
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.
citation: Buchmann I, Henze M, Engelbrecht S, Eisenhut M, Runz A, Schafer 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. doi: 10.1007/s00259-007-0450-1. Epub 2007 May 23.
citation: Calais J, Czernin J, Eiber M, Fendler WP, Gartmann J, Heaney AP, Hendifar AE, Pisegna JR, Hecht JR, Wolin EM, Slavik R, Gupta P, Quon A, Schiepers C, Allen-Auerbach MS, Herrmann K. Most of the Intended Management Changes After 68Ga-DOTATATE PET/CT Are Implemented. J Nucl Med. 2017 Nov;58(11):1793-1796. doi: 10.2967/jnumed.117.192450. Epub 2017 May 4.