The Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer
NCT ID: NCT01159405
Last Updated: 2014-07-30
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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UNKNOWN
PHASE1
9 participants
INTERVENTIONAL
2010-06-30
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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99mTc-GP
99mTc-GP with SPECT/CT imaging \& whole body scan.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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SeeCure LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Tejal Patel, M.D.
Role: PRINCIPAL_INVESTIGATOR
Breast Medical Oncologist, Methodist Cancer Center, Houston, Texas
Locations
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Houston Methodist Hospital
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SeeCure GP-001
Identifier Type: -
Identifier Source: org_study_id
NCT01374529
Identifier Type: -
Identifier Source: nct_alias
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