TheranosticTrials.org

Clinical Trial · NCT01572701

Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection

Overview

This is a single arm, open label study of up to 24 high risk prostate cancer patients scheduled for prostatectomy and/or pelvic lymph node dissection. Patients receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard of care, patients will undergo prostatectomy and/or pelvic lymph node dissection (PLND) within two weeks of study drug dosing. Patients may receive a second injection of study drug within 24 hours of surgery to measure activity counts in tissue samples post-surgery, but prior to pathology processing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.

Sponsor

Bivision Pharmaceuticals, Inc.

Phase

Phase 1

Contacts

Douglas S Scherr, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01572701

Drug / Compound

MIP-1404

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Participant is deemed to be high-risk with potential for pelvic lymph node involvement. The criteria for high-risk are:
  • 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.
  • Have had (within previous 2 months) or will undergo diagnostic CT or MRI imaging prior to surgery.
  • Past biopsy indicating the presence of adenocarcinoma of the prostate gland.
  • Patient has PSA value \>20 and clinical stage T2 or higher, and Gleason score
  • Patient has PSA value \>10 and clinical stage T2 or higher, and Gleason score 8, 9 or 10.
  • Participant is or will be scheduled to undergo standard of care prostatectomy and/or pelvic lymph node dissection.
  • Have had (within previous 2 months) or will undergo bone scan imaging prior to surgery.

Exclusion

  • 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.
  • 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.