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 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.

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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

New York Presbyterian Hospital, Weill Cornell Medical College

New York, 10065, United States

Who can participate

Healthy volunteers accepted: Yes

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.
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

Treatment and study plan

99mTc-MIP-1404

Drug

Primary outcomes

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

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Molecular Insight Pharmaceuticals, Inc.

Industry

Registry information

Important dates

Study start: 2012
Primary completion: 2013
First posted: Aug 1, 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.

Published trials that share one or more normalized conditions with this study.

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