Study to Evaluate the Safety, Pharmacokinetics, Tissue Distribution, Metabolism and Dosimetry of Two Prostate Cancer Imaging Agents
NCT ID: NCT00712829
Last Updated: 2011-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2008-05-31
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
SINGLE
Study Groups
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1
123-I-MIP-1072 administration followed by 123-I-MIP-1095 administration two weeks later.
123-I-MIP-1072
10 mCi intravenous injection given one time during the study
123-I-MIP-1095
10 mCi intravenous injection given one time during the study
2
123-I-MIP-1095 administration followed by 123-I-MIP-1072 administration two weeks later.
123-I-MIP-1072
10 mCi intravenous injection given one time during the study
123-I-MIP-1095
10 mCi intravenous injection given one time during the study
Interventions
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123-I-MIP-1072
10 mCi intravenous injection given one time during the study
123-I-MIP-1095
10 mCi intravenous injection given one time during the study
Eligibility Criteria
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Inclusion Criteria
* Have evidence of recurrent metastatic disease demonstrated by an abnormal bone scan, CT scan or MRI plus:
1. PSA\> 1.0 if patient is post prostatectomy or post ablative radiotherapy, or
2. PSA\> 20 if intact prostate
* Have platelet count of \> 50,000/mm3
* Have neutrophil count of \> 1,000/mm3
* Provide written informed consent and willing to comply with protocol requirements
* Greater than or equal to 18 years of age
* Can be on hormonal therapy if dose stable for \> 90 days
Exclusion Criteria
* Inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and PK blood sampling, respectively)
* Patient received a permanent prostate brachytherapy implant within the last 3 months (for Pd-103 implants) or 12 months (for I-125 implants).
* Patient received external beam therapy or chemotherapy within the last 30 days
* Administered a radioisotope within 5 physical half lives prior to study enrollment
* Serum creatinine \> 3.5 mg/dL
* Total bilirubin \> 2.5 times the upper limit of normal
* Liver transaminases greater than 5x the upper limit of normal
* Received an investigational compound and/or medical device or is part of an investigational study within the past 30 days before enrollment into this study
* Have any medical condition or other circumstances which, in the opinion of the Investigator, would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations
* Is determined by the Investigator that the patient is clinically unsuitable for the study
* Have had any other malignancies within 5 years other than basal or squamous cell carcinoma of the skin.
18 Years
MALE
No
Sponsors
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Molecular Insight Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Johns Hopkins Medical Institutes - Neuroradiology Division
Baltimore, Maryland, United States
New York Weill Cornell Medical Center - New York Presbyterian Hospital
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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TX-P101
Identifier Type: -
Identifier Source: org_study_id