Clinical trial NCT01615406: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: Molecular Insight Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-06-08
Enrollment: 9
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate
timeFrame: Within 3-6 hours of dosing SPECT/CT images will be taken
Secondary outcomes:
measure: 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
timeFrame: 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
measure: Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of pelvic lymph node
timeFrame: Within 3-6 hours of dosing SPECT/CT images will be taken
measure: Intensity of 99mTc-MIP-1404 uptake with respect to PSMA expression
timeFrame: PSMA expression analysis will be conducted upon completion of enrollment
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center - Houston
state: Texas
Study officials:
affiliation: Vanguard Urologic Research Foundation, University of Texas, Houston
name: Kevin Slawin, M.D.
role: PRINCIPAL_INVESTIGATOR
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