CT Scan for Breast Cancer

Overseen By Rheese Mcnab

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must be taking: Anthracyclines, Taxanes, HER2 therapy

Disqualifiers: Systemic metastases, Chronic kidney disease, 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)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how often breast cancer spreads after chemotherapy and surgery. It focuses on using CT scans (a detailed x-ray) to detect cancer spread in patients with specific types of breast cancer: triple negative, HER2+, and hormone receptor positive (HR+). The study seeks individuals who have undergone chemotherapy and surgery for node-positive breast cancer. Understanding this spread will help improve follow-up care and treatment plans for future patients. Participants need to be available for about 6 months. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group, offering participants a chance to contribute to advancements in breast cancer care.

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 trial coordinators or your doctor.

What prior data suggests that CT scans are safe for breast cancer patients?

Research has shown that CT scans are a commonly used and well-tolerated imaging tool in medical settings. Imaging can be challenging for triple-negative breast cancer due to the aggressive nature of the tumors. However, CT scans remain a part of regular diagnostic practices and are generally safe.

Studies on HER2-positive breast cancer found that PET/CT imaging did not harm participants, suggesting that similar methods, like CT scans, are usually safe for patients.

For hormone receptor-positive breast cancer, the disease tends to progress more slowly. Imaging, including CT scans, is a standard part of managing this type of cancer, with no specific evidence indicating safety concerns for these patients.

Overall, CT scans are a routine part of cancer care and are generally considered safe for different types of breast cancer. They are non-invasive and provide important information without significant risk to patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using CT scans for breast cancer because this imaging technique might offer a more detailed view of tumors compared to standard options like mammograms and MRIs. CT scans can capture cross-sectional images, allowing doctors to better understand the size and spread of the cancer. This could be especially important for types like triple-negative, HER2+, and hormone receptor-positive breast cancers, where precise imaging is crucial for tailoring specific treatment strategies. By providing clearer pictures, CT scans could improve diagnosis accuracy and help in planning more effective treatments.

What evidence suggests that CT scans are effective for detecting systemic metastasis in breast cancer?

This trial will evaluate the use of CT scans for different types of breast cancer. Research has shown that CT scans help detect the spread of breast cancer, particularly across various types. For participants with triple-negative breast cancer in this trial, combining CT scans with chemotherapy can enhance patient care by showing a higher rate of complete response. In the HER2-positive breast cancer arm, studies indicate that CT scans help identify cancer traits and monitor treatment effectiveness. For those with hormone receptor-positive breast cancer, CT scans assist in understanding treatment patterns and outcomes, despite the wide variation in this type. These findings suggest that CT scans are valuable tools for managing and monitoring breast cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Kamran Ahmed

Principal Investigator

Moffitt Cancer Center

Matthew Mills

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with breast cancer who have positive lymph nodes after chemotherapy and surgery. They must be scheduled for adjuvant radiation therapy and willing to undergo CT scans of the thorax, abdomen, and pelvis at the start of the study and again at 6 months if initial scans are negative.

Inclusion Criteria

My breast cancer is HER2+ or triple negative and spread to lymph nodes after initial chemo.

Ability to understand and willingness to comply with all study procedures and availability for the duration of the study

My breast cancer's ER/PR/HER2 status is documented.

Exclusion Criteria

Contraindication towards CT IV contrast

My cancer has spread to other parts of my body.

My kidney function is very low (stage IV, V, or end-stage).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline CT Screening

Participants undergo a computed tomography (CT) screening of the thorax, abdomen, and pelvis at baseline prior to adjuvant radiation therapy

1 week

1 visit (in-person)

Adjuvant Radiation Therapy

Participants receive adjuvant radiation therapy following baseline CT screening

4-6 weeks

Follow-up CT Screening

Participants undergo another CT screening of the thorax, abdomen, and pelvis at 6 months if the baseline CT is found to be negative

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CT Scan

Trial Overview The study aims to find out how often systemic metastasis occurs in node-positive breast cancer patients by using CT scans before and after adjuvant radiation therapy over a period of about 6 months.

How Is the Trial Designed?

Group I: Triple negative Experimental Treatment 1 Intervention

Participants diagnosed with triple negative breast cancer.

Group II: Hormone receptor (HR)+ Experimental Treatment 1 Intervention

Participants diagnosed with hormone receptor (HR)+ breast cancer.

Group III: HER2+ Experimental Treatment 1 Intervention

Participants diagnosed with HER2+ breast cancer.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Florida Breast Cancer Foundation

Collaborator

Trials

4

Recruited

310+

Published Research Related to This Trial

In a study of 1396 breast cancer patients, non-enhanced CT (NECT) demonstrated moderate sensitivity for detecting newly developed metastasis, with per-patient sensitivities of 68.3% and 53.8%, and high sensitivity for bone metastasis at 98.9%.

NECT is a viable follow-up option for patients with breast cancer who have decreased renal function or hypersensitivity to iodinated contrast media, despite its inadequate performance in evaluating hepatic metastasis response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy of non-contrast abdominopelvic computed tomography scans in follow-up of breast cancer patients. Nam, SY., Ahn, SJ., Jang, YR., et al.[2022]

CT scans of breast cancer patients showed that using intravenous contrast material during brachial injection created artifacts that hindered the interpretation of the chest wall, suggesting it should be avoided for clearer results.

Positioning patients with their arms at their sides during CT scans improved image clarity, especially for those with arm weakness or lymphedema, highlighting the importance of patient positioning in obtaining interpretable scans post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chest wall after mastectomy. Part I. CT appearance of normal postoperative anatomy, postirradiation changes, and optimal scanning techniques. Shea, WJ., de Geer, G., Webb, WR.[2016]

A survey of 75 emergency physicians revealed that many ordered CT scans for reasons such as consultant requests or to appease patients, highlighting a potential overuse of CT scans in emergency settings.

After an educational session on the risks of CT scans, physicians showed a significant increase in the belief that informed consent is necessary and expressed a greater intention to discuss the risks and benefits of CT with patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of education on physician attitudes toward computed tomography utilization and consent. Weigner, MB., Dewar, KM., Basham, HF., et al.[2022]

In a study of 642 blunt trauma patients, the estimated risk of cancer death from CT radiation exposure was only 0.1%, indicating that the risk of radiation is relatively low compared to the risk of trauma mortality.

The findings suggest that in intermediate level trauma patients, especially older individuals, the risk of death from trauma is significantly higher than the risk from radiation, highlighting the need for careful consideration of CT scans in younger patients with less severe injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of trauma mortality and estimated cancer mortality from computed tomography during initial evaluation of intermediate-risk trauma patients. Laack, TA., Thompson, KM., Kofler, JM., et al.[2016]

In a study of 34 women with breast cancer, combined PET/CT imaging was able to identify 149 malignant foci in 24 patients, demonstrating its effectiveness in detecting potential cancerous activity when tumor markers were elevated but no metastases or local recurrence were confirmed.

The PET/CT showed significantly higher sensitivity and specificity compared to PET or CT alone, making it a valuable tool for monitoring breast cancer patients and improving diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

F-18-fluoro-2-deoxyglucose positron emission tomography/computed tomography in the follow-up of breast cancer with elevated levels of tumor markers. Haug, AR., Schmidt, GP., Klingenstein, A., et al.[2015]

The average breast organ dose from chest CT scans for 200 female patients was 15 mGy, with a range from 6.5 to 28 mGy, indicating variability in radiation exposure based on hospital and equipment used.

The lifetime attributable risk (LAR) of breast cancer from these scans was significantly higher in younger women (0.05% for ages 15-29) compared to older women (0.001% for ages 60-79), highlighting that the risk decreases with age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ESTIMATION OF FEMALE RADIATION DOSES AND BREAST CANCER RISK FROM CHEST CT EXAMINATIONS. Lahham, A., ALMasri, H., Kameel, S.[2018]

In a study of female patients over 40 with malignant breast lesions, contrast enhancement on cone-beam breast-CT (CBBCT) was found to significantly differentiate between breast cancer subtypes, with Luminal A lesions showing the highest contrast enhancement compared to other subtypes.

The study suggests that CBBCT could be a useful tool in personalizing treatment strategies for breast cancer patients, as the level of contrast enhancement correlates with immunohistochemical subtype and the proliferative potential of the tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast Enhancement on Cone-Beam Breast-CT for Discrimination of Breast Cancer Immunohistochemical Subtypes. Uhlig, J., Fischer, U., von Fintel, E., et al.[2020]

Dedicated breast CT offers a promising alternative to traditional mammography, especially for women with dense breast tissue, by providing high-resolution 3D images that can improve diagnostic accuracy for detecting abnormalities.

Breast CT has a similar radiation dose to that of standard mammography and can evaluate suspicious features from multiple angles in a single scan, making it a potentially valuable tool for both diagnosis and monitoring treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential role of dedicated 3D breast CT as a diagnostic tool: review and early clinical examples. O'Connell, AM., Karellas, A., Vedantham, S.[2021]

A study of 75,968 patients who underwent CT scans over a mean follow-up of 7.6 years found that indication bias is unlikely to significantly affect cancer risk estimates for colorectal and female breast cancers.

For lung cancer, some indication bias was observed, particularly in patients with unknown reasons for CT scans or those scanned for abnormal findings, but it is expected to have only a small impact on risk estimates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there Unmeasured Indication Bias in Radiation-Related Cancer Risk Estimates from Studies of Computed Tomography? Meulepas, JM., Hauptmann, M., Lubin, JH., et al.[2022]

A dedicated breast CT system has been developed and tested on 55 women, showing excellent anatomical detail and visualization of tumors, especially when using iodine contrast, which enhances tumor detection.

The breast CT system is designed to use radiation doses comparable to standard two-view mammography, making it a potentially safe alternative for breast cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computed tomography for imaging the breast. Boone, JM., Kwan, AL., Yang, K., et al.[2019]

In a study of 69 patients with metastatic renal cell carcinoma, dynamic contrast-enhanced CT scans revealed that blood volume and blood flow measurements (specifically BVdeconv, BVpatlak, and BFdeconv) were strongly associated with patient outcomes like overall survival and progression-free survival.

The study highlighted the importance of standardizing imaging protocols, as the reproducibility of these measurements was crucial for their clinical application, with BVdeconv, BVpatlak, and BFdeconv showing the most reliable results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of patient outcome endpoints to identify the best functional CT imaging parameters in metastatic renal cell carcinoma patients. Mains, JR., Donskov, F., Pedersen, EM., et al.[2019]

A custom-tailored breast shielding device for abdominal CT scans significantly reduces radiation exposure to breast tissue, achieving a 57% dose reduction compared to no shielding, which is crucial given the associated breast cancer risk from radiation exposure.

Conventional anterior shielding also provided a notable 42% dose reduction, highlighting the importance of using effective shielding methods during imaging procedures to protect sensitive breast glandular tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EFFICIENCY OF BREAST SHIELDING DEVICE IN OUT-OF-PLANE COMPUTERIZED TOMOGRAPHY IMAGING OF THE ABDOMEN - PRELIMINARY RESULTS. Leder, NI., Popić, J., Knežević, Ž., et al.[2023]

A study involving 67 patients showed that breast CT using a conventional body scanner is as effective as dedicated CT/M mammography units in diagnosing both malignant and benign breast lesions.

While breast CT cannot replace conventional mammography for routine screening, it offers unique advantages in detecting cancers that are not visible through other methods, particularly in cases of suspected breast cancer or when evaluating complex findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computed tomographic mammography using a conventional body scanner. Chang, CH., Nesbit, DE., Fisher, DR., et al.[2016]

Multidetector computed tomography (MCT) effectively assesses tumor size and lymph node status in advanced breast cancer patients, showing a strong correlation between MCT measurements and actual tumor size post-chemotherapy (Pearson correlation coefficient of 0.76).

MCT demonstrated moderate sensitivity (72%) and accuracy (66.7%) in detecting axillary lymph node metastases after neoadjuvant chemotherapy, highlighting the potential for false negatives in identifying micrometastases, which could impact treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidetector computed tomography assessment on tumor size and nodal status in patients with locally advanced breast cancer before and after neoadjuvant chemotherapy. Cheung, YC., Chen, SC., Hsieh, IC., et al.[2016]

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Clinicopathological characteristics, treatment patterns and ... This study reveals the high heterogeneity of HER2-positive breast cancer related to HR status in clinicopathological features, metastasis patterns, and ...

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Healthcare costs and health outcomes analysis of ... Research article. Healthcare costs and health outcomes analysis of Neoadjuvant Trastuzumab therapy for HER2 positive breast cancer.

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Real-world treatment patterns and outcomes among ... This study aimed to describe treatment patterns and outcomes in patients with HER2-positive unresectable or metastatic breast cancer in the real ...

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64Cu-DOTA-Trastuzumab PET Imaging in Patients with HER2 ... The purpose of this study was to determine the safety, distribution, internal dosimetry, and initial human epidermal growth factor receptor 2 ( ...

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[89Zr]Trastuzumab: Evaluation of Radiation Dosimetry, Safety ... We observed no adverse effects in any of our 12 subjects. We found excellent delineation of tumor lesions by [89Zr]trastuzumab PET/CT in woman with HER2- ...

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HER2-Positive Breast Cancer Clinical Trials This study will examine the safety and effectiveness of pertuzumab combined with high-dose trastuzumab in adult patients who have HER2-positive breast cancer ...