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Gallium-68 Prostate Specific Membrane Antigen PET in Diagnosing Patients With Thyroid Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03463889
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : August 10, 2020
Sponsor:
Information provided by (Responsible Party):
Robert Flavell, MD, PhD, University of California, San Francisco

Brief Summary:
This pilot clinical trial studies how well Gallium-68 prostate specific membrane antigen positron emission tomography (PET) work in diagnosing patients with thyroid cancer. Diagnostic procedures, such as 68Ga-PSMA PET, may more accurately diagnose thyroid cancer and find out how far the disease has spread.

Condition or disease Intervention/treatment Phase
Thyroid Gland Carcinoma Drug: Gallium Ga 68-labeled PSMA-11 Procedure: Magnetic Resonance Imaging Procedure: Positron Emission Tomography (PET) Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the feasibility and utility of Gallium Ga 68-labeled PSMA-11 (68Ga-PSMA) PET imaging in patients with thyroid cancer.

SECONDARY OBJECTIVES:

I. To assess the correlation between targeted molecular uptake of 68Ga-PSMA PET in thyroid cancer compared to areas identified as tumor by radioiodine uptake (in well-differentiated cancers) or fludeoxyglucose F-18 (18F-FDG) uptake (in poorly differentiated and/or radioiodine-negative cancers).

II. To determine and compare the sensitivity and specificity of 68Ga-PSMA PET to (18F-FDG) PET and/or radioiodine scintigraphy.

TERTIARY OBJECTIVES:

I. To determine if 68Ga-PSMA PET uptake is related to tumor differentiation and PSMA staining in tissue pathology when available.

II. To determine the correlation between standardized uptake value maximum (SUVmax) of target thyroid cancer lesions on 68Ga-PSMA PET and serum thyroglobulin levels.

OUTLINE:

Participants receive 68Ga-PSMA intravenously (IV) over 1-2 minutes and then undergo PET/MRI 60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Gallium-68 Prostate Specific Membrane Antigen (68Ga-PSMA) PET for Imaging of Thyroid Cancer: A Feasibility Study
Actual Study Start Date : March 19, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Gallium

Arm Intervention/treatment
Experimental: Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)
Participants receive 68Ga-PSMA IV over 1-2 minutes and then undergo PET/MRI 60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan.
Drug: Gallium Ga 68-labeled PSMA-11
Given IV
Other Names:
  • 68Ga-HBED-CC-PSMA
  • 68Ga-PSMA-11
  • [68Ga] Prostate-specific Membrane Antigen 11
  • [68Ga]GaPSMA-11
  • Ga-68 labeled PSMA-11
  • Gallium Ga 68 PSMA-11

Procedure: Magnetic Resonance Imaging
Undergo MRI in combination with PET
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • MRI Scan
  • Nuclear Magnetic Resonance Imaging (NMRI)
  • Nuclear Magnetic Resonance (NMR) Imaging
  • NMRI

Procedure: Positron Emission Tomography (PET)
Undergo PET in combination with MRI
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. Number of Gallium-68 prostate specific membrane antigen (68Ga PSMA-11) positron emission tomography (PET) - positive lesions [ Time Frame: Up to 24 months ]
    Will be descriptively reported for each patient and correlated with the lesions observed in standard magnetic resonance imaging (MRI).

  2. Number of overall detected thyroid cancer lesions [ Time Frame: Up to 24 months ]
    Will be descriptively reported for each patient and correlated with the lesions observed in standard MRI.

  3. Standardized uptake value maximum (SUVmax) [ Time Frame: Up to 24 months ]
    Mean SUVmax across all visualized lesions per patient will be descriptively reported.

  4. Comparison of SUVmax-average (avg) by group [ Time Frame: Up to 24 months ]
    The patient cohort will be dichotomized by thyroglobulin level. The mean SUVmax-avg between dichotomized subgroups will be compared using the non-parametric Mann-Whitney U test and across all patients in the study cohort will be descriptively reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of thyroid cancer
  • Whole body 18F-FDG PET/computed tomography (CT) or I-131 scintigraphy within the past 90 days of the scheduled 68Ga-PSMA PET demonstrating uptake
  • Creatinine =< 3.0 mg/dL
  • Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria:

  • Patients who have had active infection within 15 days of study enrollment that may be considered to interfere with 68Ga-PSMA PET imaging by the study investigators
  • Patients who are unable to have placement of intravenous line access
  • Pregnant or breastfeeding women
  • Patients not capable of undergoing a PET/MRI study due to weight, claustrophobia, or inability to lie still for the duration of the exam

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): NCT03463889


Contacts
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Contact: Madeleine Welsh 877-827-3222 cancertrials@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Madeleine Welsh    877-827-3222    cancertrials@ucsf.edu   
Principal Investigator: Robert Favell, MD, PhD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Robert Flavell, MD, PhD University of California, San Francisco
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Responsible Party: Robert Flavell, MD, PhD, Asst Professor in Residence, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03463889    
Other Study ID Numbers: 172016
NCI-2018-00055 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020
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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Edetic Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action