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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Molecular Insight Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Male aged 21 years or older.

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

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

• Participant is deemed to have tissue suspicious of prostate cancer involvement that is amenable to biopsy/resection.

• Have had, or will undergo diagnostic CT or MRI imaging prior to surgery.

• 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.

Exclusion Criteria:

• 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.

• 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.