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

November 23, 2015 updated by: Molecular Insight Pharmaceuticals, Inc.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue distribution of 20 (± 3) mCi 99mTc-MIP-1404
Time Frame: Post-procedure
99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.
Post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Summary tables will present change from pre-dose to post-dose vital signs measurements.
Vital signs measurements will be measured, an expected average of 30 minutes before and after study drug injection
Intensity of 99mTc-MIP-1404 Uptake with Respect to PSMA expression
Time Frame: Post-procedure
99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.
Post-procedure
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
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.
Adverse events will be assessed for the duration of the study participation, an expected average of 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Molecular Insight Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Douglas S Scherr, MD, New York Presbyterian Hospital - Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

December 5, 2011

First Submitted That Met QC Criteria

April 4, 2012

First Posted (ESTIMATE)

April 6, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 25, 2015

Last Update Submitted That Met QC Criteria

November 23, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIP-TcTx-P104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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