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Carbon-11 Labeled Sarcosine in Prostate Cancer

NCT ID: NCT02462447

Last Updated: 2017-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-02-08

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer

Keywords

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prostate cancer biopsy PET

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

11C-sarcosine

Intervention Type DRUG

Radiotracer injection for PET/CT scan

11C-choline

Intervention Type DRUG

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.

11C-sarcosine

Intervention Type DRUG

Radiotracer injection for PET/CT scan

Interventions

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11C-sarcosine

Radiotracer injection for PET/CT scan

Intervention Type DRUG

11C-choline

Radiotracer injection for PET/CT scan

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Morand Piert, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Morand R Piert, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Hospital

Locations

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University of Michigan Health Systems

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Piert M, Shao X, Raffel D, Davenport MS, Montgomery J, Kunju LP, Hockley BG, Siddiqui J, Scott PJH, Chinnaiyan AM, Rajendiran T. Preclinical Evaluation of 11C-Sarcosine as a Substrate of Proton-Coupled Amino Acid Transporters and First Human Application in Prostate Cancer. J Nucl Med. 2017 Aug;58(8):1216-1223. doi: 10.2967/jnumed.116.173179. Epub 2017 Mar 16.

Reference Type RESULT
PMID: 28302759 (View on PubMed)

Other Identifiers

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R21CA191052-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00091201

Identifier Type: -

Identifier Source: org_study_id