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

Trial Summary

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 data supports the effectiveness of the treatment CT Scan for Breast Cancer?

CT scans, including specific types like multidetector CT and cone-beam breast-CT, have been shown to be useful in assessing tumor size, nodal status, and distinguishing breast cancer subtypes, which can help in planning treatment and monitoring progress. ^{1 2 3 4 5}

Is a CT scan generally safe for humans?

CT scans involve exposure to radiation, which can slightly increase the risk of cancer, including breast cancer. The risk varies based on age and the specific parameters of the scan, but it is generally low and consistent with global studies. Using protective devices can reduce radiation exposure to sensitive areas like the breast. ^{6 7 8 9 10}

How does CT scan differ from other breast cancer treatments?

CT scans for breast cancer offer a unique advantage by providing detailed 3D images of the breast, which can help detect cancers that are not visible with traditional mammography, especially in dense breast tissue. This method also allows for better visualization of soft tissue and microcalcifications, potentially improving diagnostic accuracy and aiding in the evaluation of treatment response. ^{3 11 12 13 14}

What is the purpose of this trial?

The purpose of the study is to determine the frequency of systemic metastasis in node positive breast cancer following chemotherapy and surgery. Participants will be asked to spend about 6 months in this study. Participants will undergo a computed tomography (CT) screening of the thorax, abdomen, and pelvis at baseline prior to adjuvant radiation therapy and another CT screening of the thorax, abdomen, and pelvis at 6 months if the baseline CT is found to be negative.

Research Team

Kamran Ahmed

Principal Investigator

Moffitt Cancer Center

Matthew Mills

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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 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 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]

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 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy of non-contrast abdominopelvic computed tomography scans in follow-up of breast cancer patients. [2022]

2. England 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. [2016]

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

Contrast Enhancement on Cone-Beam Breast-CT for Discrimination of Breast Cancer Immunohistochemical Subtypes. [2020]

4. United States 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. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Use of patient outcome endpoints to identify the best functional CT imaging parameters in metastatic renal cell carcinoma patients. [2019]

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

Is there Unmeasured Indication Bias in Radiation-Related Cancer Risk Estimates from Studies of Computed Tomography? [2022]

7. Croatia pubmed.ncbi.nlm.nih.gov

EFFICIENCY OF BREAST SHIELDING DEVICE IN OUT-OF-PLANE COMPUTERIZED TOMOGRAPHY IMAGING OF THE ABDOMEN - PRELIMINARY RESULTS. [2023]

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

Impact of education on physician attitudes toward computed tomography utilization and consent. [2022]

9. England pubmed.ncbi.nlm.nih.gov

ESTIMATION OF FEMALE RADIATION DOSES AND BREAST CANCER RISK FROM CHEST CT EXAMINATIONS. [2018]

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

Comparison of trauma mortality and estimated cancer mortality from computed tomography during initial evaluation of intermediate-risk trauma patients. [2016]

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

Computed tomographic mammography using a conventional body scanner. [2016]

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

Computed tomography for imaging the breast. [2019]

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

The potential role of dedicated 3D breast CT as a diagnostic tool: review and early clinical examples. [2021]

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

Chest wall after mastectomy. Part I. CT appearance of normal postoperative anatomy, postirradiation changes, and optimal scanning techniques. [2016]