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GA-69 DOTA-TATE Imaging of Somatostatin R+ Malignancies (DOTA-TOC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02177773
First Posted: June 30, 2014
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Thomas Hope, University of California, San Francisco
  Purpose
This phase I/II trial studies how well gallium Ga 68-DOTA-TOC positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) works in imaging patients with somatostatin receptor positive tumors. Gallium Ga 68-DOTA-TOC binds to somatostatin receptor positive tumors and can be seen using a PET scan. A PET scan uses a special camera to detect energy given off from gallium Ga 68-DOTA-TOC, to make detailed pictures of areas where material accumulates in the body. Diagnostic procedures, such as gallium Ga 68-DOTA-TOC PET/CT or PET/MRI, may help find and diagnose somatostatin receptor positive tumors and help plan the best treatment.

Condition Intervention Phase
Neuroendocrine Tumor Paraganglioma Carcinoid Tumors Neuroblastoma Procedure: Computed Tomography Drug: Gallium Ga 68-Edotreotide Other: Laboratory Biomarker Analysis Procedure: Magnetic Resonance Imaging Procedure: Positron Emission Tomography Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Gallium-68 DOTA-TOC Imaging of Somatostatin Receptor Positive Malignancies

Resource links provided by NLM:


Further study details as provided by Thomas Hope, University of California, San Francisco:

Primary Outcome Measures:
  • Number of lesions as determined by gallium Ga 68-DOTA-TOC PET imaging [ Time Frame: Up to 2 weeks ]
    The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded.


Secondary Outcome Measures:
  • Clinical stage as determined by conventional imaging and re-determined by gallium Ga 68-DOTA-TOC PET imaging [ Time Frame: Up to 2 weeks ]
    All previously acquired imaging studies will be used to compare against the research scans and will constitute conventional imaging.


Estimated Enrollment: 394
Actual Study Start Date: June 2014
Study Completion Date: May 31, 2017
Primary Completion Date: May 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ga-68 DOTA-TOC PET/CT
Patients receive gallium Ga 68-DOTA-TOC IV over 1-2 minutes. Within 55-70 minutes, patients then undergo a PET/CT scan over 30-40 minutes or a PET/MRI scan over 50 minutes.
Procedure: Computed Tomography
Undergo gallium Ga 68-DOTA-TOC PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography
Drug: Gallium Ga 68-Edotreotide
Given IV
Other Names:
  • Ga-68 DOTA0-Tyr3-octreotide
  • GALLIUM EDOTREOTIDE GA-68
  • Gallium Ga 68-DOTATOC
Other: Laboratory Biomarker Analysis
Correlative studies
Procedure: Magnetic Resonance Imaging
Undergo gallium Ga 68-DOTA-TOC PET/MRI
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
Undergo gallium Ga 68-DOTA-TOC PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET SCAN
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
Procedure: Positron Emission Tomography
Undergo gallium Ga 68-DOTA-TOC PET/MRI
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET SCAN
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine if gallium Ga 68-DOTA-TOC (gallium-68 labeled DOTA-TOC) results in the delineation of more lesions than with conventional imaging.

SECONDARY OBJECTIVES:

I. To determine if the incorporation of gallium (Ga)-68 DOTA-TOC PET/CT into the management decision making process results in a change in stage of the patient.

OUTLINE:

Patients receive gallium Ga 68-DOTA-TOC intravenously (IV) over 1-2 minutes. Within 55-70 minutes, patients then undergo a PET/CT scan over 30-40 minutes or a PET/MRI scan over 50 minutes.

After completion of study, patients are followed up for 2 weeks.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Known or suspected somatostatin receptor positive tumor such as carcinoid; neuroendocrine tumor; neuroblastoma; pheochromocytoma; supporting evidence may include MRI, CT, biochemical markers, and or pathology report
  • Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)
  • Not pregnant; a negative serum pregnancy test is required for all female subjects with child-bearing potential
  • Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria:

  • Hepatic enzymes 5 times greater than the upper limits of normal
  • Serum creatinine > 3.0 mg/dL (270 uM/L)
  • Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET/CT scanner due to body mass index (BMI)
  • Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.); although at Mission Bay Hospital pediatric patients may be sedated per clinical protocol
  • 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 intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance
  • Recognized concurrent active infection
  • Previous systemic or radiation treatment for another cancer of any type within the last 2 months
  • Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02177773


Locations
United States, California
UCSF Imaging Center at China Basin
San Francisco, California, United States, 94107
UCSF Medical Center-Mount Zion
San Francisco, California, United States, 94115
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Investigators
Principal Investigator: Thomas A Hope, MD University of California, San Francisco
  More Information

Responsible Party: Thomas Hope, Assistant Professor of Radiology and Biomedical Engineering, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02177773     History of Changes
Other Study ID Numbers: CC#14453
First Submitted: June 25, 2014
First Posted: June 30, 2014
Last Update Posted: November 20, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Neuroblastoma
Neuroendocrine Tumors
Carcinoid Tumor
Paraganglioma
Carotid Body Tumor
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Paraganglioma, Extra-Adrenal
Somatostatin
Edotreotide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action