Clinical trial · Observational
Diffuse Optical Tomography (DOT) for Monitoring Response to Neoadjuvant (Preoperative) Chemotherapy in Breast Cancer
NCT01394315CI-TRIAL-00010189DOTterminatedClinicalTrials.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)
The aim of the study is to determine if DOT can detect response early in breast cancer patients undergoing neoadjuvant 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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Parameters derived from the optical images acquired with the DOT system
- timeFrame
- These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months
- description
- The primary parameters derived from the optical images acquired with the DOT system include: The volume of tumor microvasculature V, the total haemoglobin concentration (THC), and the blood volume index BVI (=VC). Other available optical parameters are: blood oxygenation in the tumor microvasculature (SO2), its spatial distribution and dynamic fluctuation; dynamic blood perfusion. These parameters will be compared with histopathological response.
Secondary outcomes (1)
- measure
- Change in DOT parameters such as BVI, SO2, blood perfusion dynamic fluctuation
- timeFrame
- These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months
- description
- The change in DOT parameters such as BVI, SO2, blood perfusion dynamic fluctuation will be correlated with response based on clinical examination, ultrasound, MMG and MRI. Standard definitions for clinical response will be used to classify patients into four categories: complete response (CR), partial response (PR), progressive disease (PD) and stable disease (SD).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patients receiving neoadjuvant chemotherapy for breast cancer. * Patients with locally advanced breast tumours or large operable tumours who require neoadjuvant treatment for downstaging. * Histological confirmation of invasive breast carcinoma. * Patients with metastatic disease may be eligible if they have oligometastatic disease and breast surgery after neoadjuvant chemotherapy is planned. * Signed informed consent * Age equal to or more than 21 years * Life expectancy greater than 12 weeks. * ECOG performance status 0-2 Exclusion Criteria: * Fungating or ulcerated tumours * Inability to provide informed consent * Anticipated inability to follow-up patient for response to chemotherapy * Any contraindication to undergoing ultrasound, MRI, MMG or DOT
References
Publications (0)
Data not yet available
No reference posted for this study.