Clinical trial · Observational
Multi-scale Modeling of Breast Conserving Therapy
A Pilot Study for the Identification of Targets for Clinical Improvement in Breast Conserving Therapy
- 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 proposed study is a single-center, prospective, pilot, observation study to tabulate and measure the changes that occur during treatment and healing for breast conserving therapy (BCT) in women with non-metastatic breast cancer for comparison to the multiscale model of breast lumpectomy and healing in order to identify targets for improving BCT. The study will be comprised of 12 de novo breast cancer patients with non-metastatic breast cancer undergoing BCT. Subjects will be enrolled in the study during the 3 weeks prior to receiving their BCT surgery and will be followed for six months after the BCT surgery. A total of 6 visits (not including the surgery) are planned.
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 |
|---|---|---|---|
| Standard of Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Study Endpoint
- timeFrame
- Six-month Post-Surgery
- description
- The proportion of subjects with ≥60% agreement between the surgical/healing outcome of the lumpectomy and breast surface contour and the predicted changes from the multi-scale model.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult females ≥ age 30 years 2. Have early stage (Stage I, II), non-metastatic breast cancer 3. Planned to receive BCT 4. Have received a pre-operative mammogram within 30 days of surgery 5. Have received pre-operative magnetic resonance imaging (MRI) within 30 days of surgery 6. Planned to receive post-surgery radiotherapy by whole breast radiotherapy 7. Signed informed consent form prior to any research assessment Exclusion Criteria: 1. Adult females younger than 30 years of age 2. Previous breast cancer 3. Neo-adjuvant therapy for breast cancer 4. Pregnant or nursing females 5. Participation in a study of investigational drug in the previous 30 days or 5 half-lives of the investigational drug
References
Publications (1)
- BACKGROUNDSalmon R, Garbey M, Moore LW, Bass BL. Interrogating a multifactorial model of breast conserving therapy with clinical data. PLoS One. 2015 Apr 23;10(4):e0125006. doi: 10.1371/journal.pone.0125006. eCollection 2015. PMID 25906048