Clinical trial · Interventional
The Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer
A Pilot Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide (99mTc-GP) in Patients With Breast Cancer
NCT01159405CI-TRIAL-00015251unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiolabeled (99mTc) GP (Glycopeptide) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 99mTc-GP
- description
- 99mTc-GP with SPECT/CT imaging \& whole body scan.
- interventionNames
- Radiation: Radiolabeled (99mTc) GP (Glycopeptide)
Primary outcomes (1)
- measure
- To determine the best dose of 99mTc-GP in imaging based upon safety data and tumor-to background (T/B) count density ratios.
- timeFrame
- from 99mTc-GP injection through 30 days
Secondary outcomes (1)
- measure
- 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.
- timeFrame
- from 99mTc-GP injection through 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.