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NCT Number: NCT01615406

A Phase 1 Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging to Histology in Men With Prostate Cancer

This is a single arm, open label study of up to 24 prostate cancer patients scheduled for prostatectomy and/or pelvic lymph node dissection. Patients receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard of care, patients will undergo prostatectomy and/or pelvic lymph node dissection (PLND) within two weeks of study drug dosing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

21 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The University of Texas Health Science Center - Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male aged 21 years or older.
  • Ability to provide signed informed consent and willingness to comply with protocol requirements.
  • Past biopsy indicating the presence of adenocarcinoma of the prostate gland.
  • Participant is deemed to have tissue suspicious of prostate cancer involvement that is amenable to biopsy/resection.
  • Have had, or will undergo diagnostic CT or MRI imaging prior to surgery.
  • Participants must agree to use an acceptable form of birth control throughout the study period. Participants must use condoms for a period of seven days after study drug administration, if engaged in sexual activity.

Exclusion criteria

  • Participants for whom participating would significantly delay the scheduled standard of care therapy.
  • Participants administered a radioisotope within 5 physical half lives prior to study enrollment.
  • Participants with any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.

Treatment and study plan

99mTc MIP 1404

Drug

A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc MIP 1404

Primary outcomes

  1. Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate

    Time frame: Within 3-6 hours of dosing SPECT/CT images will be taken

    Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate (as determined by histopathology) in patients undergoing standard of care prostatectomy

Secondary outcomes

  1. Safety of 99mTc-MIP-1404 will be assessed by measuring Vital Signs (blood pressure and heart rate)Pre-Dose and Post-Dose as well as between 3-6 hours post-dose

    Time frame: Vital signs measurements will be taken, an expected average of 30 minutes before and after study drug injection and between 3-6 hours after study drug injection

    Summary tables will present change from pre-dose to post-dose vital signs measurements.

  2. Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of pelvic lymph node

    Time frame: Within 3-6 hours of dosing SPECT/CT images will be taken

    To obtain exploratory tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of pelvic lymph node

  3. Intensity of 99mTc-MIP-1404 uptake with respect to PSMA expression

    Time frame: PSMA expression analysis will be conducted upon completion of enrollment

    Evaluate the intensity of 99mTc-MIP-1404 uptake with respect to PSMA expression

Sponsors and collaborators

Lead sponsor

Molecular Insight Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase 1 Pilot Comparison Study of 99mTc-MIP-1404 Single Photon Emission Computed Tomography (SPECT)/CT Imaging to Histology in Men With Prostate Cancer

Important dates

Study start
2012
Primary completion
2012
First posted
Jun 8, 2012
Registry last updated
Nov 25, 2015

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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