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A Phase 1 Pilot Comparison Study of 99mTc-MIP-1404 Single Photon Emission Computed Tomography (SPECT)/CT Imaging to Histology in Men With Prostate Cancer


Phase 1
21 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

A Phase 1 Pilot Comparison Study of 99mTc-MIP-1404 Single Photon Emission Computed Tomography (SPECT)/CT Imaging to Histology in Men With Prostate Cancer


Inclusion Criteria:



- Male aged 21 years or older.

- Ability to provide signed informed consent and willingness to comply with protocol
requirements.

- Past biopsy indicating the presence of adenocarcinoma of the prostate gland.

- Participant is deemed to have tissue suspicious of prostate cancer involvement that
is amenable to biopsy/resection.

- Have had, or will undergo diagnostic CT or MRI imaging prior to surgery.

- Participants must agree to use an acceptable form of birth control throughout the
study period. Participants must use condoms for a period of seven days after study
drug administration, if engaged in sexual activity.

Exclusion Criteria:

- Participants for whom participating would significantly delay the scheduled standard
of care therapy.

- Participants administered a radioisotope within 5 physical half lives prior to study
enrollment.

- Participants with any medical condition or other circumstances that, in the opinion
of the investigator, would significantly decrease obtaining reliable data, achieving
study objectives or completing the study.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate

Outcome Description:

Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate (as determined by histopathology) in patients undergoing standard of care prostatectomy

Outcome Time Frame:

Within 3-6 hours of dosing SPECT/CT images will be taken

Safety Issue:

No

Principal Investigator

Kevin Slawin, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanguard Urologic Research Foundation, University of Texas, Houston

Authority:

United States: Food and Drug Administration

Study ID:

MIP-1404-105

NCT ID:

NCT01615406

Start Date:

April 2012

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

The University of Texas Health Science Center - Houston Houston, Texas  77030