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CompletedNCT00712829Updated Oct 12, 2011

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

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

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years and older
Sex
Male
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Study summary

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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • Prostate cancer
  • Imaging
03

In context

Prostatic Neoplasms

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 →

Lead sponsor

Molecular Insight Pharmaceuticals, Inc. is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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:

    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

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.
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Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    1

    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

  • Experimental
    2

    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

Interventions

  • Drug123-I-MIP-1072

    10 mCi intravenous injection given one time during the study

  • Drug123-I-MIP-1095

    10 mCi intravenous injection given one time during the study

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What researchers measure

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

07

Study locations

3 sites
  • Johns Hopkins Medical Institutes - Neuroradiology Division
    Baltimore, Maryland 21287, United States
  • New York Weill Cornell Medical Center - New York Presbyterian Hospital
    New York, New York 10021, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00712829
Lead sponsor
Molecular Insight Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Jul 10, 2008
Start date
May 2008
Primary completion
Jan 2009
Completion
Jan 2009
Last update
Oct 12, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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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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