Clinical trial · Observational
Near Infrared/ Ultrasound Dual Modal Imaging for Breast Cancer Diagnosis
A Prospective Pilot Clinical Trial Evaluating the Utility of a Dynamic Near Infrared Imaging Device for Characterizing Suspicious Breast Lesions
NCT00499980CI-TRIAL-00000791NIRcompletedClinicalTrials.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 purpose of this study is to evaluate a dynamic near infrared imaging device for characterizing suspicious breast lesions
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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Non-pregnant (as defined by previous tubal ligation, no menses for last 12 consecutive months, or a negative quantitative serum pregnancy test on the day of the procedure.) * Age: 18 years or older * Suspicious lesion (BIRAD 4 or 5) identified by mammography and/or by ultrasound. * A breast biopsy has been scheduled * The suspicious lesion size is between 0.5 cm and 2 cm. * The suspicious lesion depth is less than 3 cm from skin surface. * The suspicious lesion should be clearly evident by ultrasound imaging Exclusion Criteria: * Patient with the biopsy performed to the suspicious lesion in the past 2 months on the same breast will be excluded from the study * Patient with tattoos overlying the area of the suspicious lesion will be excluded from the study * Patients with prior breast radiation therapy will be excluded from the study * Patients with prior breast reduction surgery or breast augmentation surgery to the same breast will be excluded from the study * Patients with previous surgical biopsy at or near the site of the suspicious lesion will be excluded from the study * Patients with prior history of breast cancer in the same breast will be excluded from the study * Patient who does not sign the consent form will be excluded from the study * Patients that have not completed all studies of mammography and/or clinical ultrasound, P-Scan, Terason ultrasound and biopsy will be excluded from this study.
References
Publications (0)
Data not yet available
No reference posted for this study.