Clinical trial NCT01654874: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: Molecular Insight Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-01
Enrollment: 6
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 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:
measure: To determine the pharmacokinetics, biodistribution and tumor uptake of 99mTc-MIP-1404 preparations in patients with confirmed metastatic prostate adenocarcinoma and in healthy volunteers
timeFrame: 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.
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital, Weill Cornell Medical College
state: New York
Study officials:
affiliation: Department of Nuclear Medicine, New York Presbyterian Hospital, Weill Cornell Medical College
name: Stanley J Goldsmith, MD
role: PRINCIPAL_INVESTIGATOR
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