TheranosticTrials.org

Clinical Trial · NCT01279785

A Pilot Study of 123I-MIP-1072 SPECT/CT Imaging With Optional Compact Gamma Camera Probe Imaging in Men With Prostate Cancer Undergoing Prostatectomy

Overview

This is a single arm, open label study of up to 20 patients with prostate cancer scheduled for prostatectomy at the NIH Clinical Center. 123I-MIP-1072 image data will be evaluated for visible uptake and compared with histopathology.

Sponsor

Bivision Pharmaceuticals, Inc.

Contacts

Peter Choyke, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01279785

Drug / Compound

MIP-1072

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

Eligibility

Inclusion

  • Participant must be scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the NIH Clinical Center.
  • ECOG Performance grade of 0 to 2. (see Appendix 1)
  • Participants of childbearing potential must agree to use an acceptable form of birth control, defined as abstinence, barrier or other acceptable, effective contraceptive method until 7 days after the infusion of study drug.
  • Have had or will undergo multiparametric endorectal coil 3T MR at the NIH clinical center
  • Recent (within 12 months of study entry) trans-rectal biopsy indicating the presence of adenocarcinoma of the prostate gland

Exclusion

  • Subjects who have received androgen deprivation therapy.
  • Subjects must not have prostate biopsies performed within 12 weeks before imaging; or within 8 weeks before imaging providing that the absence of hemorrhage is confirmed by MR imaging.
  • Participants for whom participating would significantly delay the scheduled standard of care therapy.
  • SGOT and SGPT ≥ 2 x of the upper limits of normal; total bilirubin, of ≥ 1.5 x the upper limits of normal or ≥ 3.0 mg/dl in patients with Gilbert's syndrome.
  • Patients with severe claustrophobia unresponsive to oral anxiolytics
  • Subjects 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.
  • Subjects weighing ≥350 lbs or are unable to fit within the imaging gantry
  • Administered a radioisotope within 5 physical half lives prior to study enrollment.