DBT-TOBI Imaging for Monitoring Chemotherapy Response in Breast Cancer

Overseen By Steven J Isakoff, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must be taking: HER2 therapy

Disqualifiers: Breast implants, Pregnancy, Others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4-6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new scan called DBT-TOBI, a diagnostic imaging technique, to determine if it can predict how certain breast cancers respond to chemotherapy. The focus is on triple-negative or HER2+ breast cancer, known for being more aggressive. The trial uses this scan before and during chemotherapy to monitor changes. Women receiving chemotherapy at Massachusetts General Hospital with these specific breast cancer types might be suitable candidates. Participants should not have open wounds or recent breast surgeries. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future breast cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that DBT-TOBI is safe for monitoring chemotherapy response in breast cancer?

Research has shown that imaging techniques like DBT-TOBI, which combines 3D mammography with a special light-based scan, track changes in breast tissue during chemotherapy. This helps doctors assess the effectiveness of the treatment.

In studies using DBT-TOBI, no serious side effects were reported. The procedure resembles a regular mammogram, where the breast is compressed to obtain clear images. Although some individuals might find this pressure uncomfortable, it is generally well-tolerated.

Overall, previous findings suggest that DBT-TOBI safely monitors breast cancer patients' responses to chemotherapy, with minimal risks involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about DBT-TOBI imaging for monitoring chemotherapy response in breast cancer because it offers a non-invasive way to assess how well a patient is responding to treatment. Unlike standard imaging methods, DBT-TOBI combines digital breast tomosynthesis with optical breast imaging, potentially providing more detailed insights into tumor changes over time. This approach might allow doctors to adjust treatment plans more quickly and accurately, improving patient outcomes by tailoring therapies to individual responses.

What evidence suggests that DBT-TOBI is effective for monitoring chemotherapy response in breast cancer?

Research has shown that digital breast tomosynthesis (DBT) effectively diagnoses breast cancer, providing clearer images than regular mammograms. In this trial, participants will undergo imaging with a combination of DBT and near-infrared tomographic optical imaging (TOBI), known as DBT-TOBI, to predict breast cancer's response to chemotherapy. Early findings suggest that DBT-TOBI could track treatment response in certain breast cancer types, such as triple-negative and HER2+. This method might make it easier to determine if chemotherapy is effective before surgery. Although more research is needed, initial studies indicate that DBT-TOBI has the potential to improve treatment monitoring. ^{1 3 6 7 8}

Who Is on the Research Team?

Steven Isakoff, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for women over 18 with measurable triple negative or HER2+ breast cancer, who are getting neoadjuvant chemotherapy at MGH. They must understand and sign consent. Exclusions include open breast wounds, recent surgery or biopsy, implants, pregnancy intent, certain medical/psychiatric risks, and MRI-specific criteria like claustrophobia or metal in the body.

Inclusion Criteria

I have a tumor in my breast that is at least 10 mm large.

Ability to understand and the willingness to sign a written informed consent document

My breast cancer is either HER2 positive or triple negative, as confirmed by tests.

Exclusion Criteria

For patients who agree to participate in the optional MRI study, these following additional exclusion criteria also apply:

Medical or psychiatric conditions which, in the opinion of the investigator, might result in risk to the subject from participation in the study or inability to complete the study.

Patients who are pregnant or trying to become pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants undergo baseline DBT-TOBI scans to measure initial hemoglobin concentration and oxygen saturation levels

1 week

1 visit (in-person)

Treatment

Participants receive neoadjuvant chemotherapy with DBT-TOBI scans before cycle 2 and cycle 3 to monitor response

4-6 months

3 visits (in-person) for imaging

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-6 months

What Are the Treatments Tested in This Trial?

Interventions

• DBT-TOBI

Trial Overview The study tests if DBT-TOBI scans can predict how well triple negative or HER2+ breast cancers respond to pre-surgery chemo. It combines a 3D mammogram with near-infrared imaging to monitor changes in the tumor during treatment.

How Is the Trial Designed?

Group I: DBT-TOBI Experimental Treatment 2 Interventions

* Subjects will be imaged using DBT-TOBI at the time points indicated in the Study Calendar (Baseline, before cycle 2, and additional optional time points). * Both breasts will be measured in turn. * Each breast is symmetrically centered on the x-ray detector/optical illuminator and is first compressed according to standard mammography procedures to determine the amount of force needed for each given patient * An optional Magnetic Resonance Imaging TOBI (MRI-TOBI) scan will also be performed.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 50 patients with stages II and III breast cancer, traditional methods like physical examination and mammography were found to be more effective than Tc-99m-sestamibi scintigraphy in predicting the response to neoadjuvant chemotherapy, with sensitivities of 86.5% and 83.3% respectively.

The study concluded that Tc-99m-sestamibi scintigraphy does not provide useful predictive information regarding chemotherapy response, as there were no significant correlations found between isotope uptake, clearance, and markers of chemo-resistance or tumor angiogenesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of response to neoadjuvant chemotherapy using breast scintigraphy in breast cancer]. Baena-Cañada, JM., Partida-Palma, F., Palomo-González, MJ., et al.[2019]

Citations

1. withpower.com withpower.com/trial/phase-breast-neoplasms-1-2019-4dba0

DBT-TOBI Imaging for Monitoring Chemotherapy ... Trial Overview The study tests if DBT-TOBI scans can predict how well triple negative or HER2+ breast cancers respond to pre-surgery chemo. It combines a 3D ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10726607/

Comparative Evaluation of Contrast-Enhanced Spectral ... The aim of this study was to evaluate the efficacy of contrast-enhanced spectral mammography (CESM) and digital breast tomosynthesis (DBT) in the diagnosis and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03822312?intr=Tobramycin&viewType=Table&rank=2

A Pilot Study of Tomographic Optical Breast Imaging (DBT- ... Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

4. cancer.gov cancer.gov/clinicaltrials/NCI-2019-01766

DBT-TOBI Scan in Monitoring Response to Chemotherapy ... This trial studies how well digital breast tomosynthesis guided near-infrared tomographic optical breast imaging (DBT-TOBI) scan works in monitoring response ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10996419/

Contrast-enhanced digital breast tomosythesis and ... Overall, on 77% of occasions patients preferred CE-DBT with no difference between pre-treatment and end-of-treatment imaging. Overall experience (p = 0.008), ...

6. clinicaltrial.be clinicaltrial.be/en/details/65437?only_active=0&only_eligible=0&only_recruiting=0&per_page=100

A Pilot Study of Tomographic Optical Breast Imaging (DBT-... In this study, the DBT-TOBI will be used to scan the breast. The data that can be collected through the scan is the total hemoglobin ...

7. trial.medpath.com trial.medpath.com/clinical-trial/91ddab8f7c6b4952/nct03822312-pilot-study-digital-breast-tomosynthesis-optical-breast-imaging

A Pilot Study of Tomographic Optical Breast Imaging (DBT ... In this study, the DBT-TOBI will be used to scan the breast. The data that can be collected through the scan is the total hemoglobin concentration and ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2642986/

Combined Optical Imaging and Mammography of the Healthy ... In this paper, we report new progress in developing the instrument and software platform of a combined X-ray mammography/diffuse optical breast imaging ...