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

• Status: Withdrawn
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Molecular Insight Pharmaceuticals, Inc.
• Collaborator: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Participant must be scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the NIH Clinical Center.

• 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

• Participant must be 18 years or older.

• ECOG Performance grade of 0 to 2. (see Appendix 1)

• Ability to understand and provide informed consent. All subjects must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.

• 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.

Exclusion Criteria:

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

• 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.

• Administered a radioisotope within 5 physical half lives prior to study enrollment.

• Patients with severe claustrophobia unresponsive to oral anxiolytics

• Subjects weighing ≥350 lbs or are unable to fit within the imaging gantry

• Subjects who have received androgen deprivation therapy.

• 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.