Back to results68Ga DOTATATE PET/CT in Neuroendocrine Tumors (Expanded Access)
Primary Purpose
Carcinoid Cancer, Neuroendocrine Tumors, Medullary Thyroid Cancer
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
68Ga DOTATATE
Sponsored by
About this trial
This is an expanded access trial for Carcinoid Cancer
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.
Sites / Locations
- UCLA Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT02174679
First Posted
June 20, 2014
Last Updated
July 23, 2020
Sponsor
Jonsson Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02174679
Brief Title
68Ga DOTATATE PET/CT in Neuroendocrine Tumors (Expanded Access)
Official Title
68Ga-DOTATATE Imaging in Neuroendocrine Tumors
Study Type
Expanded Access
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoid Cancer, Neuroendocrine Tumors, Medullary Thyroid Cancer, Cancers Expressing Somatostatin Receptors
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
68Ga DOTATATE
Other Intervention Name(s)
68Ga DOTATATE PET/CT Scan
Intervention Description
Patients with somatostatin receptor positive tumors will be evaluated with 68Ga-DOTATATE PET/CT.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Czernin, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15570748
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. doi: 10.1016/s1479-666x(03)80092-6.
Results Reference
background
PubMed Identifier
16917396
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.
Results Reference
background
PubMed Identifier
22144556
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.
Results Reference
background
PubMed Identifier
20596866
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.
Results Reference
background
PubMed Identifier
17520251
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.
Results Reference
background
PubMed Identifier
28473600
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.
Results Reference
derived
Links:
URL
http://pet.ucla.edu
Description
UCLA Ahmanson Translational Imaging Division
Learn more about this trial
68Ga DOTATATE PET/CT in Neuroendocrine Tumors (Expanded Access)
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