A Study of 99mTc-MIP-1404 and 99mTc-MIP-1405 in Patients With Metastatic Prostate Adenocarcinoma and Healthy Volunteers
NCT ID: NCT01261754
Last Updated: 2015-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
SINGLE
Study Groups
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Metastatic prostate adenocarcinoma
99mTc MIP 1404
Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1404
99mTc MIP 1405
Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1405
Healthy Volunteers
99mTc MIP 1404
Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1404
99mTc MIP 1405
Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1405
Newly Diagnosed, High-Risk Prosate Cancer Patients
99mTc MIP 1404
Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1404
99mTc MIP 1405
Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1405
Interventions
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99mTc MIP 1404
Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1404
99mTc MIP 1405
Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1405
Eligibility Criteria
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Inclusion Criteria
1. Male aged 21 years or older.
2. Ability to provide signed informed consent and willingness to comply with protocol requirements.
3. Participants must agree to use condoms for a period of seven days after each injection, if engaged in sexual activity.
i. Histologic diagnosis of prostate cancer by validated medical history. (Pathology report, if available).
ii. Evidence of metastatic disease demonstrated by a documented abnormal bone scan, CT scan, or MRI plus a Clinical Stage 3 and Gleason Score ≥ 8.
iii. Karnofsky performance is ≥ 60.
i. PSA laboratory assessment within normal range (PSA \< 4 ng/ml). ii. Normal findings on a digital rectal examination. iii. Hemoglobin and hematocrit within normal range.
Exclusion Criteria
1. Received an investigational compound and/or medical device or is part of an investigational study within the past 30 days before enrollment into this study.
2. Subject was administered a radioisotope within 5 physical half lives of that radioisotope prior to study enrollment
3. 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.
4. Participant is determined by the Investigator to be clinically unsuitable for the study.
5. Serum creatinine ≥ 2.0 mg/dl
6. Total bilirubin ≥ 2.0 mg/dl
7. Liver transaminases ≥ 1.5 x ULN
8. Platelet count \< 150,000/mm3
9. Absolute neutrophil count (ANC) \< 2,000/mm3.
10. Hematocrit \< 30% or hemoglobin \< 10 g/dl.
11. Abnormal coagulation profile (PT, PTT or INR) \> 1.3 ULN unless on therapeutic anticoagulation.
Patients will be excluded from the study if any of the following criteria are observed:
i. Androgen deprivation therapy or other forms of hormonal therapy not stable for a period of 14 days prior to screening.
ii. Subject has received a permanent prostate brachytherapy implant within the last 3 months for 103Pd implants; or 12 months for 125I implants.
iii. Subject on or expected to be starting cytotoxic chemotherapy during the study period.
iv. Has had any other malignancies within the past year, other than basal or squamous cell carcinoma of the skin, diagnosis and location must be defined or be defined as clinically controlled or treated to complete response.
Healthy Volunteers will be excluded from the study if any of the following criteria are observed:
i. Have had any malignancies within 5 years other than basal or squamous cell carcinoma of the skin.
ii. History of known prostate adenocarcinoma, prostate surgery/biopsy, prostatitis and/or symptoms suggestive of or associated with possible prostatitis within 6 months of enrollment.
21 Years
MALE
No
Sponsors
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Molecular Insight Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stanley J Goldsmith, MD
Role: PRINCIPAL_INVESTIGATOR
New York Presbyterian Hospital - Weill Medical College of Cornell University
Locations
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New York Presbyterian Hospital - Weill Medical College of Cornell University
New York, New York, United States
Countries
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Other Identifiers
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TcTx-P101
Identifier Type: -
Identifier Source: org_study_id