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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01615406
First received: June 4, 2012
Last updated: June 7, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: 99mTc MIP 1404
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Molecular Insight Pharmaceuticals, Inc.:

Primary Outcome 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 ] [ Designated as safety issue: No ]
    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 Outcome 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Evaluate the intensity of 99mTc-MIP-1404 uptake with respect to PSMA expression


Estimated Enrollment: 24
Study Start Date: April 2012
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug: 99mTc-MIP-1404
20 ±3 mCi intravenous (IV) injection of 99mTc MIP 1404
Drug: 99mTc MIP 1404
A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc MIP 1404

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615406

Locations
United States, Texas
The University of Texas Health Science Center - Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Molecular Insight Pharmaceuticals, Inc.
Investigators
Principal Investigator: Kevin Slawin, M.D. Vanguard Urologic Research Foundation, University of Texas, Houston
  More Information

Publications:
Wang X, Yin L, Rao P, Stein R, Harsch KM, Lee Z, Heston WD. Targeted treatment of prostate cancer. J Cell Biochem. 2007 Oct 15;102(3):571-9.

Responsible Party: Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01615406     History of Changes
Other Study ID Numbers: MIP-1404-105
Study First Received: June 4, 2012
Last Updated: June 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 19, 2014