The Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer

NCT01159405 | Unknown Phase 1

• 1 other identifier: SeeCure GP-001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• To determine the best dose of 99mTc-GP in imaging based upon safety data and tumor-to background (T/B) count density ratios.

  from 99mTc-GP injection through 30 days

Secondary Outcomes (1)

• 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.

  from 99mTc-GP injection through 30 days

Study Arms (1)

99mTc-GP

EXPERIMENTAL

99mTc-GP with SPECT/CT imaging \& whole body scan.

Radiation: Radiolabeled (99mTc) GP (Glycopeptide)

Interventions

Radiolabeled (99mTc) GP (Glycopeptide) RADIATION

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

99mTc-GP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with newly diagnosed stage I-IV breast cancer (tumor size
• cm 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• SeeCure LLC: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Glycopeptides

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Tejal Patel, M.D.

  Breast Medical Oncologist, Methodist Cancer Center, Houston, Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Tsao, PhD

CONTACT

7135719410; ning.tsao@seecurellc.com

Chung Wei Huang, Master

CONTACT

7135719410; huangchungwei@seecurellc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 9, 2010
• Study Start: June 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 30, 2014

Record last verified: 2014-07

Locations

US (1)