Clinical trial · Interventional
Positron Emission Tomography Before Surgery in Evaluating Women With Primary or Recurrent Breast Cancer
A Pilot Study To Assess The Utility Of 18F-Fluorodeoxyglucose Positron Emission Tomography (PET) In The Pre-Operative Evaluation Of Patients With Primary And Recurrent Breast Carcinoma
NCT00039286CI-TRIAL-00020333completedPhase 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)
RATIONALE: Imaging procedures such as positron emission tomography (PET) may improve the ability to detect the extent of breast cancer. PURPOSE: Diagnostic trial to study the effectiveness of PET to detect the extent of breast cancer in women who have primary or recurrent breast cancer.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fludeoxyglucose F 18 | Radiation | — | UNRESOLVED |
| positron emission tomography | Procedure | — | UNRESOLVED |
| radionuclide imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Positron Emission Tomography
- description
- Patients receive fludeoxyglucose F 18 IV. Approximately 1 hour later, patients undergo positron emission tomography imaging. Some patients may undergo a repeat scan in 4-6 months.
- interventionNames
- Procedure: positron emission tomography
- Procedure: radionuclide imaging
- Radiation: fludeoxyglucose F 18
Primary outcomes (1)
- measure
- Determine the sensitivity, specificity, and accuracy
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of breast cancer for which surgical intervention is planned * Large primary breast cancer (i.e., larger than 5 cm, T3) as determined by prior biopsy, physical exam, or mammogram OR * Locally advanced breast cancer (T4) OR * Clinical suspicion of axillary nodal disease (N1-2) (i.e., stage IIB-IIIA) OR * Locally or regionally recurrent disease * No locally recurrent disease that is non-invasive (i.e., ductal carcinoma in situ) * No locally advanced disease (e.g., inflammatory breast cancer) that will be treated with neoadjuvant chemotherapy without surgery * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * Not specified Sex: * Female Menopausal status: * Not specified Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No other malignancy except previously treated nonmelanoma skin cancer or carcinoma in situ of the cervix * No known active infection * No autoimmune disease or inflammatory disease (e.g., sarcoidosis or rheumatoid arthritis) * Able to fast for 6 hours and tolerate a FDG-PET scan for the duration of the test * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * See Disease Characteristics
References
Publications (0)
Data not yet available
No reference posted for this study.