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Clinical Trial · NCT00534274
Positron Emission Tomography Using 3'-Deoxy-3'-(18F) Fluorothymidine in Treating Women With Locally Advanced Cancer in One Breast Who Are Receiving Chemotherapy
Overview
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using 3'-deoxy-3'-(18F) fluorothymidine, may be effective in assessing the response to chemotherapy before surgery in treating locally advanced breast cancer. PURPOSE: This clinical trial is studying how well positron emission tomography using 3'-deoxy-3'-(18F) fluorothymidine works in treating women with locally advanced cancer in one breast who are receiving chemotherapy.
Sponsor
UNICANCER
Phase
N/A
Contacts
Olivier Couturier, MD (STUDY_CHAIR)
ClinicalTrials.gov
NCT00534274Drug / Compound
FLT
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- cytosolic thymidine kinase 1
Ligand Class: Small Molecules
Eligibility
Inclusion
- Histologically confirmed unilateral breast cancer
- Negative for c-erbB2 by immunohistochemistry (IHC)
- T2 or T3, any N, M0
- Planning neoadjuvant chemotherapy comprising anthracyclines and/or taxanes, alone or combined
- Measurable disease by ultrasound
- Hormone receptor status not specified
- Unifocal by mammography and ultrasound
Exclusion
- Bilateral disease
- Impossible to receive study therapy due to geographical, social, or psychological reasons
- Prisoners or patients under supervisionPRIOR CONCURRENT THERAPY:Inclusion criteria:
- Fertile patients must use effective contraceptionExclusion criteria:
- Hematologic, hepatic, and renal function normal
- Cutaneous invasion, major adherence, or inflammatory disease
- Multifocal tumor
- Invasive grade I lobular cancer
- Menopausal status not specified
- Female
- Tumor overexpressing c-erbB2 by IHC (HER 2+++)
- Metastatic disease
- Alcohol dependency or prior reaction to ethanol injection
- Suspected clinical or radiological lesion (examined or not)PATIENT CHARACTERISTICS:Inclusion criteria:
- Participation in another concurrent therapeutic study with an experimental drug
- See Disease CharacteristicsExclusion criteria:
- Stage ≥ T4 disease
- Not pregnant or nursing
- ECOG performance status 0-1
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