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OpenTrials
Completed

NCT Number: NCT00712829

Study to Evaluate the Safety, Pharmacokinetics, Tissue Distribution, Metabolism and Dosimetry of Two Prostate Cancer Imaging Agents

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Johns Hopkins Medical Institutes - Neuroradiology Division, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have a prior histological diagnosis of prostate cancer.
  • Have evidence of recurrent metastatic disease demonstrated by an abnormal bone scan, CT scan or MRI plus:
  • PSA> 1.0 if patient is post prostatectomy or post ablative radiotherapy, or
  • 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

  • Karnofsky performance status of <60
  • 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.

Treatment and study plan

123-I-MIP-1072

Drug

10 mCi intravenous injection given one time during the study

123-I-MIP-1095

Drug

10 mCi intravenous injection given one time during the study

Primary outcomes

  1. 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.

Secondary outcomes

  1. To examine whole body excretion and metabolism of 123-I-MIP-1072 and 123-I-MIP-1095 in patients with recurrent metastatic prostate cancer.

  2. 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.

  3. Optimize imaging parameters

Sponsors and collaborators

Lead sponsor

Molecular Insight Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase I Study Evaluating the Safety, Pharmacokinetics, Tissue Distribution, Metabolism of Small Molecule Inhibitors of Prostate Specific Membrane Antigen: Determination of I-123 Radiation Dosimetry for 123-I-MIP-1072 and 123-I-MIP-1095

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 10, 2008
Registry last updated
Oct 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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