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99mTc-MIP-1404 for Imaging Prostate Cancer: Phase I Clinical Study to Assess the Image Quality of a Simplified Kit Formulation Compared to a Multi-step Preparation of 99mTc-MIP-1404

This study is currently recruiting participants.
Verified September 2012 by Molecular Insight Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01654874
First received: July 30, 2012
Last updated: September 12, 2012
Last verified: September 2012
History of Changes
  Purpose

This trial is a single-blind, cross-over design. Up to three patients with confirmed metastatic prostate adenocarcinoma and up to three healthy volunteers will receive two doses of 20.0 (± 3) mCi of intravenously administered 99mTc MIP 1404 (preparation A or preparation B). Whole-body planar scintigraphic images will be acquired at various time points on the day of study drug administration. A pelvic SPECT/CT image will be acquired on the day of study drug administration. Blood will be collected for pharmacokinetic measurements following study drug administration. Each participant will receive an initial study drug administration (preparation A) and a second study drug administration (preparation B) approximately 7 to 21 days later. A final follow-up visit will occur approximately 2 - 3 weeks after the second study drug administration.


Condition Intervention Phase
Prostate Cancer
 Drug: 99mTc-MIP-1404
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: 99mTc-MIP-1404 for Imaging Prostate Cancer: Phase I Clinical Study to Assess the Image Quality of a Simplified Kit Formulation Compared to a Multi-step Preparation of 99mTc-MIP-1404

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Molecular Insight Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • To assess the image quality of a simplified kit formulation of 99mTc-MIP-1404 (study drug) compared to a multi-step preparation of 99mTc-MIP-1404 in patients with confirmed metastatic prostate adenocarcinoma and in healthy volunteers [ Time Frame: Whole-body planar scintigraphic images will be acquired at 30 min, 2 and 4 hours post administration. A pelvic SPECT/CT image will be acquired at 3 hours post study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the pharmacokinetics, biodistribution and tumor uptake of 99mTc-MIP-1404 preparations in patients with confirmed metastatic prostate adenocarcinoma and in healthy volunteers [ Time Frame: Blood will be collected for PK and radioactivity counting at baseline, 2 minutes, 5 minutes, 30 minutes, 1 hour, 2 hours, and 4 hours post study drug administration. ] [ Designated as safety issue: No ]

Estimated Enrollment: 6
Study Start Date: July 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Preparation A
20 (±3) mCi 99mTc-MIP-1404 (preparation A)
 Drug: 99mTc-MIP-1404
Experimental: Preparation B
20 (±3) mCi 99mTc-MIP-1404 (preparation B)
 Drug: 99mTc-MIP-1404

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male aged 21 years or older.
  • Ability to provide signed informed consent and willingness to comply with protocol requirements.
  • Participants must agree to use an acceptable form of birth control throughout the study period. Participants must agree to use condoms for a period of seven days after each study drug administration, if engaged in sexual activity.

Additional Inclusion Criteria for Metastatic Prostate Adenocarcinoma Patients:

  • Histologic diagnosis of prostate cancer by validated medical history (pathology report, if available).
  • Evidence of metastatic disease demonstrated by a documented abnormal bone scan, CT scan, or MRI
  • Karnofsky performance is ≥ 60

Additional Inclusion Criteria for Healthy Volunteers:

  • PSA laboratory assessment within normal range (PSA < 4 ng/ml)
  • Normal findings on a digital rectal examination
  • Hemoglobin and hematocrit within normal range

Exclusion Criteria:

  • Received a radioisotope within 5 physical half lives of that radioisotope prior to study enrollment
  • 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
  • Participant is determined by the Investigator to be clinically unsuitable for the study
  • Serum creatinine ≥ 2.0 mg/dl
  • Total bilirubin ≥ 2.0 mg/dl
  • Liver transaminases ≥ 1.5 x ULN
  • Platelet count < 100,000/mm3
  • Absolute neutrophil count (ANC) < 2,000/mm3
  • Hematocrit < 30% or hemoglobin < 10 g/dl

Additional Exclusion Criteria for Metastatic Prostate Adenocarcinoma Patients:

  • Have received a permanent prostate brachytherapy implant within the last 3 months for 103Pd implants; or 12 months for 125I implants
  • Have had any other malignancies within the past year, other than basal or squamous cell carcinoma of the skin, in which the diagnosis and location have not been defined as clinically controlled or treated to complete response
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01654874

Contacts
Contact: Brooke Heagarty 617-871-6654 bhegarty@molecularinsight.com
Contact: Robert Crummet 617-871-6715 rcrummet@molecularinsight.com

Locations
United States, New York
New York Presbyterian Hospital, Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Shankar Vallabhajosula, PhD     212-746-5694     mailto:svallabh@med.cornell.edu    
Contact: Irina Lipai     212-746-9306     irkinn.li@gmail.com    
Sponsors and Collaborators
Molecular Insight Pharmaceuticals, Inc.
Investigators
Principal Investigator: Stanley J Goldsmith, MD Department of Nuclear Medicine, New York Presbyterian Hospital, Weill Cornell Medical College
  More Information

Publications:

Responsible Party: Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01654874     History of Changes
Other Study ID Numbers: MIP-TcTx-P101b
Study First Received: July 30, 2012
Last Updated: September 12, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013