A Phase 1 interventional study of 123-I-MIP-1072 and 123-I-MIP-1095 in Prostate Cancer, sponsored by Molecular Insight Pharmaceuticals, Inc.. Completed at 3 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-10-12.
Sponsored by Molecular Insight Pharmaceuticals, Inc. · Phase 1, Interventional, and Diagnostic
This is a single blinded, randomized, cross-over design. Up to 12 patients will be randomly administered a single 10.0 mCi dose of 123I-MIP-1072 or 123I-MIP-1095 (study drugs). The second (alternate) study drug will be administered approximately 14 days after the first. A final follow-up visit will occur approximately 2 weeks after the injection of the alternate study drug.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 12 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Molecular Insight Pharmaceuticals, Inc. is the lead sponsor of 19 studies on the registry; none are open to participants now.
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Have evidence of recurrent metastatic disease demonstrated by an abnormal bone scan, CT scan or MRI plus:
Exclusion Criteria:
123-I-MIP-1072 administration followed by 123-I-MIP-1095 administration two weeks later.
Drug: 123-I-MIP-1072 · Drug: 123-I-MIP-1095
123-I-MIP-1095 administration followed by 123-I-MIP-1072 administration two weeks later.
Drug: 123-I-MIP-1072 · Drug: 123-I-MIP-1095
10 mCi intravenous injection given one time during the study
10 mCi intravenous injection given one time during the study
To examine the pharmacokinetics and organ radiation dosimetry of 123-I-MIP-1072 and 123I-MIP-1095 in patients with prior histological diagnosis of prostate cancer with evidence of recurrent metastatic disease.
To examine whole body excretion and metabolism of 123-I-MIP-1072 and 123-I-MIP-1095 in patients with recurrent metastatic prostate cancer.
To evaluate the safety of administering a 10.0 mCi dose of 123-I-MIP-1072 and 123-I-MIP-1095 to patients with recurrent metastatic prostate cancer.
Optimize imaging parameters
This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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Molecular Insight Pharmaceuticals, Inc.