Carbon-11 Labeled Sarcosine in Prostate Cancer

November 7, 2017 updated by: Morand Piert, MD, University of Michigan

Biodistribution and Mechanism of Action of the 11C-labeled PET Tracer Sarcosine in Patients With Prostate Cancer as Well as Radiation Dosimetry, Plasma Pharmacokinetics and Biodistribution in Healthy Volunteers

Men with and without prostate cancer will have a PET/CT scan that measures the level of the amino acid sarcosine. PET is a scanning method that uses short lived radioactivity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Tissue levels of the amino acid sarcosine are elevated in prostate cancer compared to normal prostate tissues and further increased in metastases from prostate cancer. This research project is designed to test whether 11C-sarcosine (a chemical that is linked to short lived radioactivity) would be useful to detect prostate cancer in men using PET/CT imaging. The uptake and distribution of 11C-sarcosine in men with known or suspected prostate cancer will be determined and compared with results from 11C-choline PET/CT.

Study Type

Observational

Enrollment (Actual)

20

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
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health Systems

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

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Group 1: Subjects with confirmed or suspected prostate cancer who will undergo a planned tissue biopsy of the known or suspected tumor

Group 2: Healthy volunteers.

Description

Inclusion Criteria:

  • Males 40 years of age or older
  • Confirmed or suspected prostate cancer and will undergo a planned tissue biopsy of the known or suspected tumor (Prostate Cancer Group 1 only)

Exclusion Criteria:

  • Active malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
  • Body weight > 350 lbs (158 kg)
  • Prisoners
  • Subject not willing or able to sign informed consent

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prostate Cancer
Subjects will receive two PET/CT examinations, one with 11C-sarcosine and one with 11C-choline. These scans will take 30-45 minutes each.
Drug: 11C-sarcosine
Radiotracer injection for PET/CT scan
Drug: 11C-choline
Radiotracer injection for PET/CT scan
Healthy Volunteer
Subjects will receive one PET/CT examination, with 11C-sarcosine. This scan will take approximately 90 minutes.
Drug: 11C-sarcosine
Radiotracer injection for PET/CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of biodistribution of 11C-sarcosine in prostate cancer patients
Time Frame: One Month
One Month
Evaluation of radiation dosimetry of 11C-sarcosine in healthy volunteers
Time Frame: One Month
One Month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the uptake measures of 11C-sarcosine with those from 11C-choline
Time Frame: One Month
Standardized uptake (SUV) values from tumor tissues relative to background, also called tumor-to-background ratios (TBR), will be determined from both, 11C-sarcosine and 11C-choline. Then TBR measurements from 11C-choline and 11C-sarcosine will be compared to identify whether 11C-sarcosine improves tumor to background image contrast relative to 11C-choline in prostate cancer.
One Month
Evaluation of underlying metabolic pathways of sarcosine in prostate cancer tissues obtained from tissue materials
Time Frame: One Month
One Month
Evaluation of the relationship between sarcosine (and metabolite) tissue concentrations and 11C-sarcosine/11C-choline plasma and tissue uptake measures
Time Frame: One Month
One Month

Collaborators and Investigators

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

Sponsor

University of Michigan

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Morand R Piert, MD, University of Michigan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2015

Primary Completion (ACTUAL)

February 8, 2017

Study Completion (ACTUAL)

February 8, 2017

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

June 1, 2015

First Posted (ESTIMATE)

June 4, 2015

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2017

Last Update Submitted That Met QC Criteria

November 7, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00091201
  • R21CA191052-01 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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