Back to resultsThe Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Radiolabeled (99mTc) GP (Glycopeptide)
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer
Eligibility Criteria
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.
Sites / Locations
- Houston Methodist HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
99mTc-GP
Arm Description
99mTc-GP with SPECT/CT imaging & whole body scan.
Outcomes
Primary Outcome Measures
To determine the best dose of 99mTc-GP in imaging based upon safety data and tumor-to background (T/B) count density ratios.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01159405
Brief Title
The Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer
Official Title
A Pilot Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide (99mTc-GP) in Patients With Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SeeCure LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
99mTc-GP
Arm Type
Experimental
Arm Description
99mTc-GP with SPECT/CT imaging & whole body scan.
Intervention Type
Radiation
Intervention Name(s)
Radiolabeled (99mTc) GP (Glycopeptide)
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ning Tsao, PhD
Phone
7135719410
Email
ning.tsao@seecurellc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chung Wei Huang, Master
Phone
7135719410
Email
huangchungwei@seecurellc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tejal Patel, M.D.
Organizational Affiliation
Breast Medical Oncologist, Methodist Cancer Center, Houston, Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eileen Dickman, PhD, MBA, CCRC
Phone
713-441-9777
Email
edickman@houstonmethodist.org
First Name & Middle Initial & Last Name & Degree
Andrea Dotting, M.D
Phone
713-441-8029
Email
andotting@houstonmethodist.org
First Name & Middle Initial & Last Name & Degree
Tejal Patel, M.D.
First Name & Middle Initial & Last Name & Degree
Angel Rodriguez, M.D.
First Name & Middle Initial & Last Name & Degree
Daniel Y. Lee, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Jenny C-N Chang, M.B.BChir, M.D.
12. IPD Sharing Statement
Learn more about this trial
The Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer
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