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

S

SeeCure

Status and phase

Unknown
Phase 1

Conditions

Breast Cancer

Treatments

Radiation: Radiolabeled (99mTc) GP (Glycopeptide)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01159405
SeeCure GP-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

99mTc-GP
Experimental group
Description:
99mTc-GP with SPECT/CT imaging \& whole body scan.
Treatment:
Radiation: Radiolabeled (99mTc) GP (Glycopeptide)

Trial contacts and locations

1

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Central trial contact

Ning Tsao, PhD; Chung Wei Huang, Master

Data sourced from clinicaltrials.gov

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