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Update and Biodistribution of [F-18]FMDHT pET/CT in Normal Healthy Volunteers and Patients With Metastatic Prostate Cancer - A First in Human Subject Study With [F-18] FMDHT


N/A
30 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Update and Biodistribution of [F-18]FMDHT pET/CT in Normal Healthy Volunteers and Patients With Metastatic Prostate Cancer - A First in Human Subject Study With [F-18] FMDHT


Inclusion Criteria:



Normal Healthy Volunteers

- Males age 30 years or older.

- No prior history of cancer.

- Willing to get a PSA evaluated. Normal subjects will be eligible if their PSA is in
the normal range for the particular lab where it is drawn. PSA drawn within 6 months
(before) of the FMDHT PET scan will be accepted.

- Ability to tolerate PET imaging.

- Ability to understand and willingness to sign a written informed consent document.

Prostate Cancer Patients:

- Patients with histologically confirmed adenocarcinoma of the prostate.

- Patients with a clinical staging CT at the time of the first [F-18]FMDHT scan.

- Patients with at least one single focus of metastatic disease (bone/lymph node or
soft tissue) confirmed on other clinical studies, preferably biopsy.

- Patients with prior transurethral resection of the prostate are eligible.

- Ability to tolerate PET imaging.

- Males age 30 years or older.

- Ability to understand and willingness to sign a written informed consent document.

- Willing to get a PSA evaluated.

Exclusion Criteria:

Normal Health Volunteers

- Prior diagnosis of any cancer (except non-melanoma skin cancer).

Prostate Cancer Patients

- Prior diagnosis of cancer except non-melanoma skin cancer.

- Prior treatment (other than biopsy) for prostate cancer.

- Received radiation therapy, hormonal therapy, surgery or cryotherapy for prostate
disease.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To map diffusion and clearance rates of this marker in normal and cancerous tissue.

Outcome Description:

To obtain first-in-man biodistribution data for [F-18]FMDHT with PET/CT imaging in subjects with and without prostate cancer. The results of these tests will be in the form of scans. Distinguishing characteristics will be how quickly the marker clears from the tissues in the scans.

Outcome Time Frame:

Day 1

Safety Issue:

Yes

Principal Investigator

Pradeep Garg, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University

Authority:

United States: Food and Drug Administration

Study ID:

CCCWFU 85111

NCT ID:

NCT01724619

Start Date:

November 2012

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Wake Forest University Health SciencesWinston-Salem, North Carolina  27157