A Phase 1 Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging to Histology in Men With Prostate Cancer
Completed · Phase 1
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT01615406
- Run by
- Molecular Insight Pharmaceuticals, Inc.
- People needed
- 9
- Starts
- 2012-04-01
- Last updated by the study team
- 2015-11-25
Who can join
Age: 21 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The University of Texas Health Science Center - Houston — Houston, Texas, United States
Full record on ClinicalTrials.gov
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