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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment DBT-TOBI for monitoring chemotherapy response in breast cancer?

Research shows that imaging techniques like diffuse optical tomography can measure changes in breast tissue during chemotherapy, helping doctors see how well the treatment is working. This suggests that similar imaging methods, like DBT-TOBI, could be useful for monitoring chemotherapy response in breast cancer. ^{1 2 3 4 5}

How does the DBT-TOBI imaging treatment differ from other breast cancer treatments?

DBT-TOBI imaging is unique because it combines digital breast tomosynthesis (a 3D mammography technique) with diffuse optical tomography, which uses near-infrared light to measure blood-related changes in the breast. This approach helps in monitoring how well chemotherapy is working by providing detailed functional imaging of the tumor, which is different from traditional imaging methods that primarily focus on structural changes. ^{4 6 7 8 9}

Research Team

Steven Isakoff, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Diffuse optical tomography breast imaging measurements are modifiable with pre-surgical targeted and endocrine therapies among women with early stage breast cancer. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Frequent optical imaging during breast cancer neoadjuvant chemotherapy reveals dynamic tumor physiology in an individual patient. [2021]

3. Spain pubmed.ncbi.nlm.nih.gov

[Evaluation of response to neoadjuvant chemotherapy using breast scintigraphy in breast cancer]. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Determination and prediction of P-glycoprotein and multidrug-resistance-related protein expression in breast cancer with double-phase technetium-99m sestamibi scintimammography. Visual and quantitative analyses. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Predicting survival and early clinical response to primary chemotherapy for patients with locally advanced breast cancer using DCE-MRI. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of breast tumor response to neoadjuvant chemotherapy with tomographic diffuse optical spectroscopy: case studies of tumor region-of-interest changes. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Method to improve the localization accuracy and contrast recovery of lesions in separately acquired X-ray and diffuse optical tomographic breast imaging. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Effects of neoadjuvant chemotherapy on the contralateral non-tumor-bearing breast assessed by diffuse optical tomography. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

99mTc-Sestamibi, a sensitive probe for in vivo imaging of P-glycoprotein inhibition by modulators and mdr1 antisense oligodeoxynucleotides. [2022]