- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01159405
The Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer
July 29, 2014 updated by: SeeCure LLC
A Pilot Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide (99mTc-GP) in Patients With Breast Cancer
The purpose of this study is to evaluate the biodistribution and dosimetry of single dose of 99mTc-glycopeptide (99mTc-GP, 20-25 mCi) in 3 different doses of GP (5, 10and 20 mg)in patients with breast cancer at pre-chemotherapy.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Cohorts of 3 will be treated each at different dose levels and images will be taken at 4 time points.
For dosimetry estimates, there will be a 20-24 hr time point post-administration of 99mTc-GP for the first 3 patients.
If the biodistribution and dosimetry can be adequately quantified without the 20-24 hr scan in 3 patients, then we will eliminate that 4th scan for all other patients.
Urine and blood samples will be collected at 5 time points, and an additional blood and urine sample will be collected for dosimetry analysis at 30~60 min.
Study Type
Interventional
Enrollment (Anticipated)
9
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ning Tsao, PhD
- Phone Number: 7135719410
- Email: ning.tsao@seecurellc.com
Study Contact Backup
- Name: Chung Wei Huang, Master
- Phone Number: 7135719410
- Email: huangchungwei@seecurellc.com
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- Houston Methodist Hospital
-
Contact:
- Eileen Dickman, PhD, MBA, CCRC
- Phone Number: 713-441-9777
- Email: edickman@houstonmethodist.org
-
Contact:
- Andrea Dotting, M.D
- Phone Number: 713-441-8029
- Email: andotting@houstonmethodist.org
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Principal Investigator:
- Tejal Patel, M.D.
-
Sub-Investigator:
- Angel Rodriguez, M.D.
-
Sub-Investigator:
- Daniel Y. Lee, M.D., Ph.D.
-
Sub-Investigator:
- Jenny C-N Chang, M.B.BChir, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Patients with newly diagnosed stage I-IV breast cancer (tumor size
- 2cm in imaging examinations) who are scheduled to start systemic therapy.
- Patients must have histological diagnosis of invasive breast cancer.
- Extent of disease will be determined by physical examination and conventional radiological studies.
- Must be age 18 or older.
- ECOG performance status 0-2.
- Patients with history of prior malignancies must be disease-free for at least 5 years of study entry.
- Normal hematological function: WBC > 3000/ul, absolute neutrophil count > 1500/ul, platelets > 100,000/ul, and Hgb > 10 gms (transfusion to achieve Hgb > 10 gms is acceptable).
- Serum total bilirubin < 1.5 mg/dl and SGPT < 1.5 X normal.
- Adequate kidney function (creatinine < 1.5 mg/dL).
Exclusion Criteria:
- Patients who received previous chemotherapy for the newly diagnosed breast cancer.
- No evidence of primary breast lesion (e.g. T0, Tx).
- Pregnant women or sexually active women of childbearing potential who are not practicing adequate contraception are excluded.
- Patients with myocardial infarction within 6 months of study entry; unstable angina pectoris; uncontrolled congestive heart failure; uncontrolled arrhythmia are excluded.
- Patients with history of hypersensitivity/allergy to Chitosan/Chitin related shellfish foods.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 99mTc-GP
99mTc-GP with SPECT/CT imaging & whole body scan.
|
one injection of Technetium Glycopeptide to yield a target activity of 20-25 mCi to be given by slow IV push (over 3-5 minutes) 5 mg, 10 mg & 20 mg of GP will be injected
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the best dose of 99mTc-GP in imaging based upon safety data and tumor-to background (T/B) count density ratios.
Time Frame: from 99mTc-GP injection through 30 days
|
from 99mTc-GP injection through 30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the optimal time to imaging after injection of 99mTc-GP based upon tumor to-background (T/B) count density ratios at various times.
Time Frame: from 99mTc-GP injection through 30 days
|
from 99mTc-GP injection through 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tejal Patel, M.D., Breast Medical Oncologist, Methodist Cancer Center, Houston, Texas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Anticipated)
March 1, 2015
Study Completion (Anticipated)
April 1, 2015
Study Registration Dates
First Submitted
July 8, 2010
First Submitted That Met QC Criteria
July 8, 2010
First Posted (Estimate)
July 9, 2010
Study Record Updates
Last Update Posted (Estimate)
July 30, 2014
Last Update Submitted That Met QC Criteria
July 29, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SeeCure GP-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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