Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Molecular Insight Pharmaceuticals, Inc.
Age
21–any
Sex
MALE
Healthy volunteers
Accepted
You may be eligible if
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.
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
PSA laboratory assessment within normal range (PSA \< 4 ng/ml)
Normal findings on a digital rectal examination
Hemoglobin and hematocrit within normal range
You may not be if
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
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
