The Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer
This study is currently recruiting participants.
Verified June 2011 by SeeCure LLC
Sponsor:
SeeCure LLC
Information provided by (Responsible Party):
SeeCure LLC
ClinicalTrials.gov Identifier:
NCT01159405
First received: July 8, 2010
Last updated: June 5, 2012
Last verified: June 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Radiation: Radiolabeled (99mTc) GP (Glycopeptide) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | A Pilot Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide (99mTc-GP) in Patients With Breast Cancer |
Resource links provided by NLM:
Further study details as provided by SeeCure LLC:
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. [ Time Frame: from 99mTc-GP injection through 30 days ] [ Designated as safety issue: Yes ]
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. [ Time Frame: from 99mTc-GP injection through 30 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 9 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 99mTc-GP
99mTc-GP with SPECT/CT imaging & whole body scan.
|
Radiation: Radiolabeled (99mTc) GP (Glycopeptide)
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159405
Contacts
| Contact: Vicky Lo, Master | 7138937423 | vickylo@seecurellc.com |
| Contact: Chung Wei Huang, Master | 7138937423 | huangchungwei@seecurellc.com |
Locations
| United States, Texas | |
| Memorial Hermann Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Isis Gayed, M.D 713-704-1787 isis.w.gayed@uth.tmc.edu | |
| Contact: Vicki Ephron, M.D 832-265-6329 Vicki.J.Ephron@uth.tmc.edu | |
| Principal Investigator: Isis Gayed, M.D | |
Sponsors and Collaborators
SeeCure LLC
Investigators
| Principal Investigator: | Isis Gayed, M.D. | The University of Texas Health Science Center, Houston |
More Information
No publications provided
| Responsible Party: | SeeCure LLC |
| ClinicalTrials.gov Identifier: | NCT01159405 History of Changes |
| Obsolete Identifiers: | NCT01374529 |
| Other Study ID Numbers: | SeeCure GP-001 |
| Study First Received: | July 8, 2010 |
| Last Updated: | June 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013