A Phase 1 Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging to Histology in Men With Prostate Cancer
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2012 |
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
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.
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.
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.
We found this trial at
1
site
7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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