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Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01572701
First received: December 5, 2011
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


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 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)

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Tissue distribution of 20 (± 3) mCi 99mTc-MIP-1404 [ Time Frame: Post-procedure ] [ Designated as safety issue: No ]
    99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.


Secondary Outcome Measures:
  • Safety of 99mTc-MIP-1404: Change in Vital Signs from Pre-Dose to Post-Dose [ Time Frame: Vital signs measurements will be measured, an expected average of 30 minutes before and after study drug injection ] [ Designated as safety issue: No ]
    Summary tables will present change from pre-dose to post-dose vital signs measurements.

  • Intensity of 99mTc-MIP-1404 Uptake with Respect to PSMA expression [ Time Frame: Post-procedure ] [ Designated as safety issue: No ]
    99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.

  • Safety of 99mTc-MIP-1404: Summary of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Adverse events will be assessed for the duration of the study participation, an expected average of 3 weeks ] [ Designated as safety issue: No ]
    TEAEs will be summarized by the Medical Dictionary for Regulatory Activities (MedDRA) body system and preferred term, by intensity, and by causal relationship to study agent.


Estimated Enrollment: 24
Study Start Date: December 2011
Estimated Study Completion Date: April 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 20 (±3) mCi of study drug Drug: 99mTc-MIP-1404
20 (±3) mCi of study drug will be administered by IV injection as a slow bolus and flushed with approximately 10 mL of saline

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male aged 21 years or older.
  2. Ability to provide signed informed consent and willingness to comply with protocol requirements.
  3. Past biopsy indicating the presence of adenocarcinoma of the prostate gland.

  4. Participant is deemed to be high-risk with potential for pelvic lymph node involvement. The criteria for high-risk are:

    • Patient has PSA value >10 and clinical stage T2 or higher, and Gleason score 8, 9 or 10.
    • Patient has PSA value >20 and clinical stage T2 or higher, and Gleason score
  5. Participant is or will be scheduled to undergo standard of care prostatectomy and/or pelvic lymph node dissection.
  6. Have had (within previous 2 months) or will undergo diagnostic CT or MRI imaging prior to surgery.
  7. Have had (within previous 2 months) or will undergo bone scan imaging prior to surgery.
  8. 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 each injection, if engaged in sexual activity.

Exclusion Criteria:

  1. Participants for whom participating would significantly delay the scheduled standard of care therapy.
  2. Participants administered a radioisotope within 5 physical half lives prior to study enrollment.
  3. 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572701

Locations
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Molecular Insight Pharmaceuticals, Inc.
Investigators
Principal Investigator: Douglas S Scherr, MD New York Presbyterian Hospital - Weill Medical College of Cornell University
  More Information

Additional Information:
Molecular Insight Pharmaceuticals: In the Clinic  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01572701     History of Changes
Other Study ID Numbers: MIP-TcTx-P104
Study First Received: December 5, 2011
Last Updated: October 9, 2012
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 May 19, 2013