Clinical trial · Interventional
Positron Emission Tomography Using 3'-Deoxy-3'-(18F) Fluorothymidine in Treating Women With Locally Advanced Cancer in One Breast Who Are Receiving Chemotherapy
Study of Positron Emission Tomography With 3'-Deoxy-3'-[18F] Fluoro-thymidine ([18F]-FLT) for the Evaluation of Response to Neoadjuvant Chemotherapy for Cancers of the Breast
- 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)
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.
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 |
|---|---|---|---|
| 3'-deoxy-3'-[18F]fluorothymidine | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TEP FLT
- interventionNames
- Other: 3'-deoxy-3'-[18F]fluorothymidine
Primary outcomes (1)
- measure
- Intensity of tumor uptake of 3'-deoxy-3'-(18F) fluorothymidine (18F-FLT) determined visually and correlated with histological or surgical response according to Sataloff criteria
- timeFrame
- Post surgery
Secondary outcomes (7)
- measure
- Intensity of tumor uptake of 18F-FLT by standardized uptake value (SUV)
- timeFrame
- Post surgery
- measure
- Variation of tumoral uptake as seen by positron emission tomography (PET) before, during, and after therapy as determined visually and by SUV
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Inclusion criteria: * Histologically confirmed unilateral breast cancer * T2 or T3, any N, M0 * Unifocal by mammography and ultrasound * Negative for c-erbB2 by immunohistochemistry (IHC) * Planning neoadjuvant chemotherapy comprising anthracyclines and/or taxanes, alone or combined * Measurable disease by ultrasound * Hormone receptor status not specified Exclusion criteria: * Bilateral disease * Multifocal tumor * Invasive grade I lobular cancer * Metastatic disease * Stage ≥ T4 disease * Cutaneous invasion, major adherence, or inflammatory disease * Tumor overexpressing c-erbB2 by IHC (HER 2+++) * Suspected clinical or radiological lesion (examined or not) PATIENT CHARACTERISTICS: Inclusion criteria: * ECOG performance status 0-1 * Female * Menopausal status not specified * Hematologic, hepatic, and renal function normal * Not pregnant or nursing * Fertile patients must use effective contraception Exclusion criteria: * Alcohol dependency or prior reaction to ethanol injection * Impossible to receive study therapy due to geographical, social, or psychological reasons * Prisoners or patients under supervision PRIOR CONCURRENT THERAPY: Inclusion criteria: * See Disease Characteristics Exclusion criteria: * Participation in another concurrent therapeutic study with an experimental drug
References
Publications (0)
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