Clinical Trial · NCT01615406

A Phase 1 Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging to Histology in Men With Prostate Cancer

Overview

This is a single arm, open label study of up to 24 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. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.

Sponsor

Bivision Pharmaceuticals, Inc.

Phase

Phase 1

Contacts

Kevin Slawin, M.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01615406

Drug / Compound

MIP-1404

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: TIM

Eligibility

Inclusion

Participant is deemed to have tissue suspicious of prostate cancer involvement that is amenable to biopsy/resection.
Past biopsy indicating the presence of adenocarcinoma of the prostate gland.
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.
Have had, or will undergo diagnostic CT or MRI 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.