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

NCT03463889 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 172016NCI-2018-00055
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Gland Carcinoma

Outcome Measures

Primary Outcomes (3)

• Number of 68Ga PSMA-11 PET-positive Lesions

  The number of 68Ga PSMA-11 PET-positive lesions detected by staging scans will be descriptively reported.

  Up to 24 months

• Number of Overall Detected Thyroid Cancer Lesions

  The number of overall thyroid cancer lesions detected by standard staging scans will be descriptively reported

  Up to 24 months

• Mean Standardized Uptake Value Maximum of Gallium-68 PSMA (SUVmax)

  The mean and standard deviation for SUVmax across all lesions across all patients will be reported.

  Up to 6 months

Secondary Outcomes (2)

• Sensitivity of Gallium-68 PSMA for the Detection of Thyroid Cancers

  Up to 24 months

• Specificity of Gallium-68 PSMA for the Detection of Thyroid Cancers

  Up to 24 months

Study Arms (1)

Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)

EXPERIMENTAL

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; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography (PET)

Interventions

Gallium Ga 68-labeled PSMA-11 DRUG

Given IV

Also known as: 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

Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI in combination with PET

Also known as: 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

Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)

Positron Emission Tomography (PET) PROCEDURE

Undergo PET in combination with MRI

Also known as: Medical Imaging, Positron Emission Tomography, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

gallium 68 PSMA-11; Magnetic Resonance Spectroscopy; X-Rays

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Limitations and Caveats

Study closed earlier than expected due to lack of funding. Due to the small sample size, comparative sub-group analyses could not be performed.

Results Point of Contact

• Title: Dr. Robert Flavell, MD PhD
• Organization: University of California, San Francisco

Robert.Flavell@ucsf.edu

877-827-3222

Study Officials

• Robert Flavell, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Professor in Residence

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: March 13, 2018
• Study Start: March 19, 2018
• Primary Completion: September 30, 2020
• Study Completion: October 31, 2020
• Last Updated: June 29, 2021
• Results First Posted: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)