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Carbon-11 Labeled Sarcosine in Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02462447
Recruitment Status : Completed
First Posted : June 4, 2015
Last Update Posted : November 9, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Morand Piert, MD, University of Michigan

Brief Summary:
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.

Condition or disease Intervention/treatment
Prostate Cancer Drug: 11C-sarcosine Drug: 11C-choline

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.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: 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
Study Start Date : June 2015
Actual Primary Completion Date : February 8, 2017
Actual Study Completion Date : February 8, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




Primary Outcome Measures :
  1. Evaluation of biodistribution of 11C-sarcosine in prostate cancer patients [ Time Frame: One Month ]
  2. Evaluation of radiation dosimetry of 11C-sarcosine in healthy volunteers [ Time Frame: One Month ]

Secondary Outcome Measures :
  1. 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.

  2. Evaluation of underlying metabolic pathways of sarcosine in prostate cancer tissues obtained from tissue materials [ Time Frame: One Month ]
  3. Evaluation of the relationship between sarcosine (and metabolite) tissue concentrations and 11C-sarcosine/11C-choline plasma and tissue uptake measures [ Time Frame: One Month ]

Biospecimen Retention:   Samples Without DNA

Group 1 (prostate cancer patients):

Tissue biopsies from prostate cancer lesions are performed as part of routine clinical care. These tissues will however be used for research purposes.

Group 2 (healthy men):

No biopsies are performed in volunteers.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Criteria

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

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): NCT02462447


Locations
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United States, Michigan
University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Morand R Piert, MD University of Michigan Hospital

Publications of Results:
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Responsible Party: Morand Piert, MD, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT02462447     History of Changes
Other Study ID Numbers: HUM00091201
R21CA191052-01 ( U.S. NIH Grant/Contract )
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Morand Piert, MD, University of Michigan:
prostate
cancer
biopsy
PET

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents