Clinical trial · Observational
Targeted Intraoperative Therapy Registry at Bethesda North Hospital (TARGIT)
Implementation of the Target Intraoperative Therapy Registry at Bethesda North TriHealth Hospital (TARGIT)
NCT02364960CI-TRIAL-00034500TARGITterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study site will join the TARGIT-US trial in lieu of this trial
Summary
Brief summary (as posted)
The purpose of this study is to create a registry to evaluate the use of intra-operative radiation therapy (IORT) and to study the efficacy and toxicity of breast radiotherapy given intra-operatively as a single fraction after breast conserving surgery,
Conditions
Conditions (3)
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 Tumor | Breast Neoplasm | ALIAS | 0.90 |
| Early Stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
| Neoplasm of the Breast | Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- In-breast local failure and patterns of in-breast failure
- timeFrame
- 6 months after IORT through year 10
- description
- In-breast local failure is defined as recurrence of cancer in the ipsilateral (same side) breast. Following IORT, patients will be monitored every 6 months for 3 years, and then annually in years 4 and 5 to determine if cancer has returned. In years 6 through 10 medical records will be reviewed to obtain information on participants' breast cancer status.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Age 45 or greater * Diagnosed with operable invasive breast cancer, T1 and T2 (\< 3.5 cm), N0, M0, confirmed by cytological or histological examination * Suited for breast conserving surgery * Have had an ipsilateral (same side as current cancer) diagnostic mammogram within 12 months of enrollment Exclusion Criteria: * age 44 or less * Axillary lymph node positive breast cancer * Invasive lobular cancer * Tumor size \> 3.5 cm * Extensive Intraductal Component (EIC= \> 25% of the lumpectomy specimen involved with ductal carcinoma in situ, DCIS) as assessed on surgical pathologic lumpectomy specimen * Multicentric cancer in the same breast not amenable to excision with a single lumpectomy * Inability to assess pathologic margin status * Synchronous bilateral breast cancer at the time of diagnosis. * Ipsilateral breast had a previous cancer and/or prior in-field radiation. * Patients known to have BRCA1/2 gene mutations * Neoadjuvant treatment (hormones or chemotherapy)
References
Publications (0)
Data not yet available
No reference posted for this study.