Gallium-68 Citrate PET Used in Prostate Cancer

June 15, 2023 updated by: Rahul Aggarwal

Gallium-68 Citrate PET To Detect MYC Amplification in Metastatic Castrate Resistant Prostate Cancer

This is a single center, pilot, cross-sectional imaging study investigating the use of gallium-68 citrate PET in participants with metastatic castration-resistant prostate cancer who are planning to undergo a metastatic tumor biopsy on protocol NCT02432001 (CC#125519).

The study population will consist of participants with metastatic castration-resistant prostate cancer who are undergoing a metastatic tumor biopsy as part of clinical protocol NCT02432001 (CC#125519), with evidence of resistance to androgen signaling inhibition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Objective:

I. To determine the association between maximum average of standard uptake value (SUVmax-ave) of target metastatic lesions on gallium-68 citrate PET with MYC amplification determined from analysis of circulating tumor DNA.

Secondary Objectives:

I. To determine the accuracy rate, sensitivity, specificity of gallium citrate PET in the detection of metastatic lesions as compared to standard staging scans including cross-sectional imaging of the abdomen/pelvis and whole body bone scan.

II. To determine the optimal dose of gallium-68 citrate and timing of scan post-injection to maximize tumor-to-background signal.

III. To characterize the safety profile of gallium-68 citrate.

Outline:

The study will involve gallium-68 PET scan obtained on a single day, followed by optional tumor biopsy within 6 weeks of gallium scan. There will be optional follow up gallium-68 citrate PET scan to assess response to treatment that will be completed within 12 weeks of baseline gallium citrate PET.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male participants with histologically confirmed prostate cancer
  • Participants must have castrate levels of testosterone (< 50 ng/dL) on Luteinizing hormone-releasing hormone (LHRH) analogue or have had prior bilateral orchiectomy, with evidence of castration-resistant disease by Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria
  • Age 18 years or older at the time of study entry
  • Minimum of at least three discrete metastatic lesions in the bone and/or soft tissue amenable to whole body Positron Emission Tomography (PET) imaging per the judgment of study radiologist

For participants who undergo optional metastatic tumor biopsy following completion of gallium citrate PET:

  • Presence of one or more metastases by standard radiographic scans that is safely accessible to tumor biopsy in the judgment of treating clinician and/or Interventional Radiology

Exclusion Criteria:

  • Contra-indications to MRI, including permanent pacemaker, implantable device, aneurysm clip, or severe claustrophobia (for participants planning to be imaged on PET/ Magnetic resonance imaging(MRI) scanner)
  • Active infection within 14 days of study enrollment

For participants who undergo optional metastatic tumor biopsy following completion of gallium citrate PET:

  • History of radiation therapy to the target metastatic lesion selected for tumor biopsy
  • Contra-indication to biopsy including uncontrolled bleeding diathesis.
  • Platelets >75,000/μl and prothrombin time (PT) or international normalized ratio (INR) and a partial prothrombin time (PTT) < 1.5 times the institutional upper limit of normal (ULN) within 14 days prior to biopsy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gallium-68 citrate, PET
Participants will receive a single scan obtained on a single day, followed by optional tumor biopsy within 6 weeks of scan. There will be optional follow up gallium-68 citrate PET scan to assess response to treatment received outside this study that will be completed within 12 weeks of baseline scan.
Drug: Gallium-68 citrate
Given via IV at time of imaging
Other Names:
  • Ga-68 citrate
  • Gallium-68 (8^Ga) citrate
Procedure: Positron Emission Tomography (PET)
Imaging procedure
Other Names:
  • PET Scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean maximum Standardized Uptake Value (SUVmax)
Time Frame: Day of imaging (1 day)
The mean and standard deviation of SUVmax of gallium-68 citrate (across all metastatic lesions per participant) will be reported.
Day of imaging (1 day)
Mean maximum Standardized Uptake Value (SUVmax-ave)
Time Frame: Day of imaging (1 day)
The mean and standard deviation of SUVmax-ave of gallium-68 citrate across all participants in the study cohort will be descriptively reported.
Day of imaging (1 day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between SUVmax and MYC gene expression
Time Frame: Day of imaging (1 day)
For participants who undergo optional tumor biopsy, with evaluable RNA sequencing data: Correlation between SUVmax on Gallium-68 Citrate PET and MYC gene expression level, reported as the Pearson correlation coefficient. The coefficient correlation has a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation.
Day of imaging (1 day)
Correlation between SUVmax and transferrin receptor gene expression
Time Frame: Day of imaging (1 day)
For participants who undergo optional tumor biopsy, with evaluable RNA sequencing data: Correlation between SUVmax on Gallium-68 Citrate PET and transferrin receptor gene expression level, reported as the Pearson correlation coefficient. The coefficient correlation has a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation.
Day of imaging (1 day)
Mean SUVmax-ave percent change from baseline
Time Frame: Up to 12 weeks
For participants who undergo optional follow up gallium-68 citrate PET scan, the mean percent change from baseline in SUVmax-ave will be descriptively reported.
Up to 12 weeks
Sensitivity of gallium-68 PET
Time Frame: Day of imaging (1 day)
Using as a cut-off to define a positive lesion on gallium-68 citrate PET as a lesion with SUV at least 1.5 times higher than mediastinal blood pool, the sensitivity value of gallium-68 PET will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including CT or MRI of the chest/abdomen/pelvis and whole body bone scan.
Day of imaging (1 day)
Specificity of gallium-68 PET
Time Frame: Day of imaging (1 day)
Using as a cut-off to define a positive lesion on gallium-68 citrate PET as a lesion with SUV at least 1.5 times higher than mediastinal blood pool, the specificity of gallium-68 PET will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including CT or MRI of the chest/abdomen/pelvis and whole body bone scan.
Day of imaging (1 day)
Positive predictive value (PPV) of gallium-68 PET
Time Frame: Day of imaging (1 day)
Using as a cut-off to define a positive lesion on gallium-68 citrate PET as a lesion with SUV at least 1.5 times higher than mediastinal blood pool, the positive predictive value of gallium-68 PET will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including CT or MRI of the chest/abdomen/pelvis and whole body bone scan.
Day of imaging (1 day)
Number of participants with reported treatment-emergent adverse events
Time Frame: Up to 12 weeks
The frequency and severity of adverse events following gallium-68 citrate injection will be descriptively reported, using CTCAE version 4.03.
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rahul Aggarwal

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Rahul Aggarwal, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2015

Primary Completion (Actual)

June 15, 2023

Study Completion (Actual)

June 15, 2023

Study Registration Dates

First Submitted

March 4, 2015

First Submitted That Met QC Criteria

March 11, 2015

First Posted (Estimated)

March 18, 2015

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 145512
  • NCI-2017-01773 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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