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A Phase 1 Pilot Study of 99mTc-MIP-1404 Single Photon Emission Computed Tomography (SPECT)/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection (PLND)


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

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Trial Information

A Phase 1 Pilot Study of 99mTc-MIP-1404 Single Photon Emission Computed Tomography (SPECT)/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection (PLND)


Inclusion Criteria:



1. Male aged 21 years or older.

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

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

4. Participant is deemed to be high-risk with potential for pelvic lymph node
involvement. The criteria for high-risk are:

- Patient has PSA value >10 and clinical stage T2 or higher, and Gleason score 8,
9 or 10.

- Patient has PSA value >20 and clinical stage T2 or higher, and Gleason score

5. Participant is or will be scheduled to undergo standard of care prostatectomy and/or
pelvic lymph node dissection.

6. Have had (within previous 2 months) or will undergo diagnostic CT or MRI imaging
prior to surgery.

7. Have had (within previous 2 months) or will undergo bone scan imaging prior to
surgery.

8. 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 each
injection, if engaged in sexual activity.

Exclusion Criteria:

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

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

3. 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 20 (± 3) mCi 99mTc-MIP-1404

Outcome Description:

99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.

Outcome Time Frame:

Post-procedure

Safety Issue:

No

Principal Investigator

Douglas S Scherr, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York Presbyterian Hospital - Weill Medical College of Cornell University

Authority:

United States: Food and Drug Administration

Study ID:

MIP-TcTx-P104

NCT ID:

NCT01572701

Start Date:

December 2011

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Weill Cornell Medical CollegeNew York, New York  10021