Clinical trial · Observational
A Pilot Study of 123I-MIP-1072 SPECT/CT Imaging With Optional Compact Gamma Camera Probe Imaging in Men With Prostate Cancer Undergoing Prostatectomy
A Phase 1 Pilot Study of 123I-MIP-1072 Single Photon Emission Computed Tomography (SPECT)/CT Imaging With Optional Compact Gamma Camera Probe Imaging in Men With Prostate Cancer Undergoing Prostatectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Similar study to be completd once kit for new formulation becomes available.
Summary
Brief summary (as posted)
This is a single arm, open label study of up to 20 patients with prostate cancer scheduled for prostatectomy at the NIH Clinical Center. 123I-MIP-1072 image data will be evaluated for visible uptake and compared with histopathology.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 123I-MIP-1072 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Prostate Cancer Patients
- description
- Male participants who are scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the NIH Clinical Center and have evidence of a recent (within 12 months of study entry) trans-rectal biopsy documenting adenocarcinoma of the prostate.
- interventionNames
- Drug: 123I-MIP-1072
Primary outcomes (1)
- measure
- To evaluate the tissue distribution of 123I-MIP-1072 SPEC/CT imaging in tumor and non-tumorous regions of the prostate (as determined by histopathology) in patients undergoing standard of care prostatectomy
- timeFrame
- Evaulated through Day 30
Secondary outcomes (5)
- measure
- To evaluate the potential of 123I-MIP-1072 imaging to predict malignancy as defined by histopathology and multiparametric 3T MR
- timeFrame
- Evaulated through Day 30
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participant must be scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the NIH Clinical Center. * Have had or will undergo multiparametric endorectal coil 3T MR at the NIH clinical center * Recent (within 12 months of study entry) trans-rectal biopsy indicating the presence of adenocarcinoma of the prostate gland * Participant must be 18 years or older. * ECOG Performance grade of 0 to 2. (see Appendix 1) * Ability to understand and provide informed consent. All subjects must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed. * Participants of childbearing potential must agree to use an acceptable form of birth control, defined as abstinence, barrier or other acceptable, effective contraceptive method until 7 days after the infusion of study drug. Exclusion Criteria: * Participants for whom participating would significantly delay the scheduled standard of care therapy. * Subjects must not have prostate biopsies performed within 12 weeks before imaging; or within 8 weeks before imaging providing that the absence of hemorrhage is confirmed by MR imaging. * SGOT and SGPT ≥ 2 x of the upper limits of normal; total bilirubin, of ≥ 1.5 x the upper limits of normal or ≥ 3.0 mg/dl in patients with Gilbert's syndrome. * Administered a radioisotope within 5 physical half lives prior to study enrollment. * Patients with severe claustrophobia unresponsive to oral anxiolytics * Subjects weighing ≥350 lbs or are unable to fit within the imaging gantry * Subjects who have received androgen deprivation therapy. * Subjects 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.
References
Publications (0)
Data not yet available