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NCT03822312 · ClinicalTrials.gov registry record · NA
A Pilot Study of Tomographic Optical Breast Imaging (DBT-TOBI) to Monitor Response to Neoadjuvant Therapy
A NA study of Breast Cancer, sponsored by Massachusetts General Hospital.
- Active
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03822312: Active NA study of Breast Cancer, sponsored by Massachusetts General Hospital.
NCT03822312 is a NA study of Breast Cancer that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 30 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03822312, a NA study of Breast Cancer, is active but no longer recruiting, sponsored by Massachusetts General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This research study is evaluating whether the use of digital breast tomosynthesis and near-infrared tomographic optical breast imaging (DBT-TOBI) scans can predict the response of triple negative or HER2+ breast cancer to neoadjuvant chemotherapy. The study radiologic scan involved in this study is digital breast tomosynthesis (also called 3 Dimensional mammogram) combined with near-infrared tomographic optical breast imaging, or DBT-TOBI.
Primary Outcome
The primary aim is to evaluate whether early measurements of the total hemoglobin concentration ratio in the primary tumor vs. the surrounding tissue, as estimated by our DBT-TOBI system, can predict neoadjuvant chemotherapy response at the time of surgery. Measurements will be obtained at baseline and just before cycle 3 to determine whether DBT-TOBI is predictive of pathological complete response (pCR) versus non-complete response for Human Epidermal Growth Factor Receptor 2 (HER2) positive an
Conditions Studied
Interventions
- DEVICE DBT-TOBI
- DEVICE MRI-TOBI
Study Locations (1)
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-02-01 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What the registry record for NCT03822312 still lists
NCT03822312 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which DBT-TOBI is the first listed.
NCT03822312 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03822312 about?
NCT03822312 is a clinical study titled "A Pilot Study of Tomographic Optical Breast Imaging (DBT-TOBI) to Monitor Response to Neoadjuvant Therapy". This research study is evaluating whether the use of digital breast tomosynthesis and near-infrared tomographic optical breast imaging (DBT-TOBI) scans can predict the response of triple negative or HER2+ breast cancer to neoadjuvant chemotherapy. The study radiologic scan involved in this study is...
What is the current status of trial NCT03822312?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2019-02-01. Estimated completion is 2026-12-31.
What conditions does trial NCT03822312 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT03822312?
The interventions under investigation include: DBT-TOBI (DEVICE), MRI-TOBI (DEVICE).
Who is sponsoring clinical trial NCT03822312?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03822312 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03822312's enrollment target sits among peer trials
30 955th of 1224 higher than 227 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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