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GA-68 DOTA-TOC of Somatostatin Positive Malignancies (DOTA-TOC)

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.
 
ClinicalTrials.gov Identifier: NCT02177773
Recruitment Status : Terminated (FDA approved agent for this indication during enrollment)
First Posted : June 30, 2014
Results First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborator:
Peterson Family Foundation
Information provided by (Responsible Party):
Thomas Hope, University of California, San Francisco

Brief Summary:
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 or disease Intervention/treatment Phase
Neuroendocrine Tumor Paraganglioma Carcinoid Tumors Neuroblastoma Procedure: Computed Tomography (CT) Drug: Gallium Ga 68-Edotreotide Procedure: Magnetic Resonance Imaging (MRI) Procedure: Positron Emission Tomography (PET) Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: N/A
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
Actual Study Start Date : June 23, 2014
Actual Primary Completion Date : August 7, 2017
Actual Study Completion Date : August 7, 2017


Arm Intervention/treatment
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 either a PET/CT scan lasting 30-40 minutes or a PET/MRI scan lasting 50 minutes.
Procedure: Computed Tomography (CT)
Undergo Gallium Ga 68-DOTA-TOC PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computed Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • Tomography

Drug: Gallium Ga 68-Edotreotide
Given Intravenously (IV) before imaging
Other Names:
  • Ga-68 DOTA0-Tyr3-octreotide
  • GALLIUM EDOTREOTIDE GA-68
  • Gallium Ga 68-DOTATOC

Procedure: Magnetic Resonance Imaging (MRI)
Undergo gallium Ga 68-DOTA-TOC PET/MRI
Other Names:
  • Magnetic Resonance Imaging
  • 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 (PET)
Undergo gallium Ga 68-DOTA-TOC PET in combination with CT or MRI
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET SCAN
  • Positron Emission Tomography
  • Positron Emission Tomography Scan
  • Proton Magnetic Resonance Spectroscopic Imaging




Primary Outcome Measures :
  1. Number of Lesions as Determined by Gallium Ga 68-DOTA-TOC Positron Emission Tomography (PET) Imaging [ Time Frame: 1 day ]
    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 The five largest lesions will be (1 = benign, 2 = likely benign, 3 = indeterminant, 4 = likely malignant, 5 = malignant). The number of positive body regions using conventional imaging and Ga-68 DOTA-TOC PET/CT will be compared using a paired t-test (or Wilcoxon signed-rank test if the data appear to be non-normally distributed). The Wilcoxon signed-rank test will also be used to compare reader confidence of paired lesions between conventional imaging and Ga-68 DOTA-TOC PET/CT

  2. Standardized Uptake Value Maximum (SUVmax) [ Time Frame: 1 day ]
    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.

  3. Inter-reader Variability [ Time Frame: 1 day ]
    Inter-reader variability for the number of positive regions will be compared using Kappa statistics. In all cases we will provide point estimates and 95% confidence intervals for effects along with p-values.


Secondary Outcome Measures :
  1. Change in Clinical Stage as Determined by Conventional Imaging and Re-determined by Gallium Ga 68-DOTA-TOC PET Imaging [ Time Frame: Up to 2 weeks ]
    Impact on care will be accessed for value added by the investigational Ga-68 DOTA-TOC PET/CT scan similar to assessment for impact on care as in the National Oncology PET registry. A percentage will then be calculated for both "Change in stage" with a 95% confidence interval determined.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
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.
  • Age > 1.
  • 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 childbearing 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 Micromole per liter (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 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

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
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Peterson Family Foundation
Investigators
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Principal Investigator: Thomas A Hope, MD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by Thomas Hope, University of California, San Francisco:
Informed Consent Form  [PDF] November 3, 2017

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Responsible Party: Thomas Hope, Assistant Professor of Radiology and Biomedical Engineering, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02177773    
Other Study ID Numbers: 14453-HDFCCC
NCI-2017-00451 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: June 30, 2014    Key Record Dates
Results First Posted: November 12, 2019
Last Update Posted: November 12, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroblastoma
Neuroendocrine Tumors
Carcinoid Tumor
Paraganglioma
Neoplasms
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Octreotide
Edotreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action