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

Overview

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.

Full Title of Study: “A Phase 1 Pilot Comparison Study of 99mTc-MIP-1404 Single Photon Emission Computed Tomography (SPECT)/CT Imaging to Histology in Men With Prostate Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2012

Interventions

  • Drug: 99mTc MIP 1404
    • A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc MIP 1404

Arms, Groups and Cohorts

  • Experimental: Drug: 99mTc-MIP-1404
    • 20 ±3 mCi intravenous (IV) injection of 99mTc MIP 1404

Clinical Trial Outcome Measures

Primary Measures

  • Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate
    • Time Frame: Within 3-6 hours of dosing SPECT/CT images will be taken
    • Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate (as determined by histopathology) in patients undergoing standard of care prostatectomy

Secondary Measures

  • Safety of 99mTc-MIP-1404 will be assessed by measuring Vital Signs (blood pressure and heart rate)Pre-Dose and Post-Dose as well as between 3-6 hours post-dose
    • Time Frame: Vital signs measurements will be taken, an expected average of 30 minutes before and after study drug injection and between 3-6 hours after study drug injection
    • Summary tables will present change from pre-dose to post-dose vital signs measurements.
  • Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of pelvic lymph node
    • Time Frame: Within 3-6 hours of dosing SPECT/CT images will be taken
    • To obtain exploratory tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of pelvic lymph node
  • Intensity of 99mTc-MIP-1404 uptake with respect to PSMA expression
    • Time Frame: PSMA expression analysis will be conducted upon completion of enrollment
    • Evaluate the intensity of 99mTc-MIP-1404 uptake with respect to PSMA expression

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Molecular Insight Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kevin Slawin, M.D., Principal Investigator, Vanguard Urologic Research Foundation, University of Texas, Houston

References

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Ghosh A, Heston WD. Tumor target prostate specific membrane antigen (PSMA) and its regulation in prostate cancer. J Cell Biochem. 2004 Feb 15;91(3):528-39. doi: 10.1002/jcb.10661.

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Barrett PH, Bell BM, Cobelli C, Golde H, Schumitzky A, Vicini P, Foster DM. SAAM II: Simulation, Analysis, and Modeling Software for tracer and pharmacokinetic studies. Metabolism. 1998 Apr;47(4):484-92. doi: 10.1016/s0026-0495(98)90064-6.

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