A Phase 1 Pilot Study of 99mTc-MIP-1404 Single Photon Emission Computed Tomography (SPECT)/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection (PLND)

NCT01572701 Phase 1 COMPLETED

This is a single arm, open label study of up to 24 high risk 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. Patients may receive a second injection of study drug within 24 hours of surgery to measure activity counts in tissue samples post-surgery, but prior to pathology processing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.

Details

Lead sponsor	Molecular Insight Pharmaceuticals, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	8
Start date	2012-01

Conditions

• Prostate Cancer

Interventions

• 99mTc-MIP-1404

Primary outcomes

• Tissue distribution of 20 (± 3) mCi 99mTc-MIP-1404 — Post-procedure
  99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.

Countries

United States