Clinical trial NCT01572701: Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: Molecular Insight Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-04-06
Enrollment: 8
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 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.


Eligibility 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.

Primary outcomes:
measure: Tissue distribution of 20 (± 3) mCi 99mTc-MIP-1404
timeFrame: Post-procedure
Secondary outcomes:
measure: Safety of 99mTc-MIP-1404: Change in Vital Signs from Pre-Dose to Post-Dose
timeFrame: Vital signs measurements will be measured, an expected average of 30 minutes before and after study drug injection
measure: Intensity of 99mTc-MIP-1404 Uptake with Respect to PSMA expression
timeFrame: Post-procedure
measure: Safety of 99mTc-MIP-1404: Summary of Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Adverse events will be assessed for the duration of the study participation, an expected average of 3 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: New York Presbyterian Hospital - Weill Medical College of Cornell University
name: Douglas S Scherr, MD
role: PRINCIPAL_INVESTIGATOR
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