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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: 99mTc-MIP-1404


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preparation A<br>20 (±3) mCi 99mTc-MIP-1404 (preparation A) | Drug: 99mTc-MIP-1404<br> <br> |
| Experimental: Preparation B<br>20 (±3) mCi 99mTc-MIP-1404 (preparation B) | Drug: 99mTc-MIP-1404<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the pharmacokinetics, biodistribution and tumor uptake of 99mTc-MIP-1404 preparations in patients with confirmed metastatic prostate adenocarcinoma and in healthy volunteers |  | 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. |