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Similar study to be completd once kit for new formulation becomes available.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
This is an exploratory, single arm, open label pilot study evaluation of 123I-MIP-1072 intraprostatic uptake determination by SPECT/CT imaging (and optional CGCP imaging), with histological confirmation of disease localization and staging. Methodical evaluation of 123I-MIP-1072 in intraprostatic tumorous and non-tumours regions will provide important preliminary data upon which further clinical studies can be based. The optional additional CGCP imaging was added, because of its inherent potential for higher resolution scintigraphic detection of 123I-MIP-1072 localization. This imaging feasibility data will provide important preliminary information for the use of CGCP imaging in prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostate Cancer Patients | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 123I-MIP-1072 | Drug | Single IV dose |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Evaulated through Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the potential of 123I-MIP-1072 imaging to predict malignancy as defined by histopathology and multiparametric 3T MR | Evaulated through Day 30 | |
| To further evaluate the safety of 123I-MIP-1072 | Evaluated through Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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Up to twenty adult men with biopsy confirmed prostate cancer scheduled for prostatectomy at the NIH Clinical Center will undergo 123I-MIP-1072 SPECT/CT and optional CGCP imaging prior to prostatectomy. These patients will also have undergone/will undergo multi-parametric 3T MR imaging at NIH which is considered standard of care at NIH clinical center.
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| Name | Affiliation | Role |
|---|---|---|
| Peter Choyke, MD | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCR/NCI - Molecular Imaging Program | Bethesda | Maryland | 20892 | United States |
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| To evaluate the intensity of 123I-MIP-1072 uptake with respect to Gleason Grade | Evaluated through Day 30 |
| To evaluate the intensity of 123I-MIP-1072 uptake with respect to PSMA expression | Evaluated through Day 30 |
| To evaluate feasibility of imaging123I-MIP-1072 uptake using an FDA-approved compact endorectal gamma camera probe (CGCP) | Evaluated through Day 30 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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