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Trial Title:
The Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer
NCT ID:
NCT01159405
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Radiolabeled (99mTc) GP (Glycopeptide)
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
Arm group label:
99mTc-GP
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Houston Methodist Hospital
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Eileen Dickman, PhD, MBA, CCRC
Phone:
713-441-9777
Email:
edickman@houstonmethodist.org
Contact backup:
Last name:
Andrea Dotting, M.D
Phone:
713-441-8029
Email:
andotting@houstonmethodist.org
Investigator:
Last name:
Tejal Patel, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Angel Rodriguez, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Daniel Y. Lee, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Jenny C-N Chang, M.B.BChir, M.D.
Email:
Sub-Investigator
Start date:
June 2010
Completion date:
April 2015
Lead sponsor:
Agency:
SeeCure LLC
Agency class:
Industry
Source:
SeeCure LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01159405
