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

Molecular Insight Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Prostate Cancer

Treatments

Drug: 99mTc MIP 1404

Study type

Interventional

Funder types

Industry

Identifiers

NCT01615406

MIP-1404-P105

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

Male

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.