Back to resultsA Phase 1 Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging to Histology in Men With Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
99mTc MIP 1404
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility 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.
Sites / Locations
- The University of Texas Health Science Center - Houston
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Drug: 99mTc-MIP-1404
Arm Description
20 ±3 mCi intravenous (IV) injection of 99mTc MIP 1404
Outcomes
Primary Outcome Measures
Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate
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
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
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
Evaluate the intensity of 99mTc-MIP-1404 uptake with respect to PSMA expression
Full Information
NCT ID
NCT01615406
First Posted
June 4, 2012
Last Updated
November 23, 2015
Sponsor
Molecular Insight Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01615406
Brief Title
A Phase 1 Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging to Histology in Men With Prostate Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molecular Insight Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug: 99mTc-MIP-1404
Arm Type
Experimental
Arm Description
20 ±3 mCi intravenous (IV) injection of 99mTc MIP 1404
Intervention Type
Drug
Intervention Name(s)
99mTc MIP 1404
Intervention Description
A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc MIP 1404
Primary Outcome Measure Information:
Title
Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate
Description
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
Time Frame
Within 3-6 hours of dosing SPECT/CT images will be taken
Secondary Outcome Measure Information:
Title
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
Description
Summary tables will present change from pre-dose to post-dose vital signs measurements.
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
Title
Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of pelvic lymph node
Description
To obtain exploratory 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
Title
Intensity of 99mTc-MIP-1404 uptake with respect to PSMA expression
Description
Evaluate the intensity of 99mTc-MIP-1404 uptake with respect to PSMA expression
Time Frame
PSMA expression analysis will be conducted upon completion of enrollment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Slawin, M.D.
Organizational Affiliation
Vanguard Urologic Research Foundation, University of Texas, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
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A Phase 1 Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging to Histology in Men With Prostate Cancer
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