FDG-PET/CT Scan Prediction for Breast Cancer

Recruiting at 87 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: ECOG-ACRIN Cancer Research Group

Must be taking: Pertuzumab

Disqualifiers: Pregnancy, Breastfeeding, High glucose, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 12-24 weeks

235 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests an imaging procedure in patients with a specific type of breast cancer. The test uses a small amount of radioactive sugar to highlight active cancer areas, helping doctors decide if more or less treatment is needed before surgery. This imaging procedure has been used successfully for diagnosis, initial staging, restaging, early treatment response assessment, evaluation of disease spread, and predicting outcomes in breast cancer.

Do I need to stop my current medications for the trial?

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

What data supports the effectiveness of the treatment involving FDG-PET/CT Scan Prediction for Breast Cancer with Chemotherapy?

Research shows that FDG-PET/CT scans are more accurate than traditional imaging methods in monitoring how well chemotherapy is working for breast cancer patients. This method can detect changes in the cancer earlier, allowing doctors to adjust treatments sooner, which may improve patient outcomes. ^{1 2 3 4 5}

Is FDG-PET/CT safe for use in humans?

FDG-PET/CT scans, which use a special sugar molecule to help see cancer activity, are generally considered safe for humans. They are commonly used in breast cancer diagnosis and treatment monitoring, and no major safety concerns have been reported in the studies reviewed. ^{1 5 6 7 8}

How does chemotherapy differ from other treatments for breast cancer?

Chemotherapy for breast cancer is unique because it uses powerful drugs to kill cancer cells, and its effectiveness can be monitored using FDG-PET/CT scans, which provide a detailed view of how the cancer is responding to the treatment. This imaging technique helps tailor the treatment to the individual, potentially avoiding unnecessary side effects and improving outcomes. ^{1 3 5 9 10}

Research Team

Heather Jacene

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

This trial is for adults (18+) with HER2-positive stage IIa-IIIc breast cancer who haven't started treatment. They must be in good health overall, not pregnant or breastfeeding, and have no history of severe illnesses that could affect the study. People with HIV can join if they're on effective therapy.

Inclusion Criteria

I have another cancer, but it won't affect this trial's treatment.

I will start my pertuzumab-based treatment within 21 days after my initial scan and after registering for the study.

My breast cancer's hormone receptor status is known, and it may be positive or negative.

Exclusion Criteria

You cannot have a medical condition that would prevent you from having a PET/CT scan, such as high blood sugar levels or severe claustrophobia.

A pregnancy test within 7 days prior to the T0 scan is also required but will only need to be done if a) the T0 scan is completed after study registration and b) if the pregnancy test done prior to registration is completed outside of the 7-day window

I am capable of becoming pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Participants receive FDG intravenously and undergo PET/CT to assess cancer activity

1 week

1 visit (in-person)

Treatment

Participants receive standard of care chemotherapy and undergo standard of care surgery

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Treatment Details

Interventions

• Chemotherapy
• Fludeoxyglucose F-18

Trial Overview The DIRECT Trial is testing whether a special imaging procedure using FDG-PET/CT scans before surgery can predict how well patients respond to standard chemotherapy for HER2-positive breast cancer.

Participant Groups

Group I: Diagnostic (FDG-PET/CT scan) Experimental Treatment 5 Interventions

Patients receive FDG IV, undergo PET/CT, receive standard of care chemotherapy, and undergo standard of care surgery on study.

Chemotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in United States as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Canada as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Japan as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in China as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Switzerland as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials

122

Recruited

160,000+

Findings from Research

In a study of 22 patients with locally advanced breast cancer, FDG-PET imaging effectively distinguished between responding tumors and nonresponding tumors after just the first course of chemotherapy, achieving 100% sensitivity and 85% specificity.

Using a standardized uptake value decrease below 55% of the baseline scan, the study found that FDG-PET could predict histopathologic response with high accuracy (88% after the first course and 91% after the second), potentially guiding treatment decisions and improving patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positron emission tomography using [(18)F]Fluorodeoxyglucose for monitoring primary chemotherapy in breast cancer. Schelling, M., Avril, N., Nährig, J., et al.[2022]

Positron emission tomography-computed tomography (PET-CT) using fluorine-18-fluoro-D-glucose (FDG) is particularly effective in detecting and staging primary invasive breast tumors and monitoring treatment response in locally advanced cases, allowing for early identification of nonresponders.

The use of PET-CT can help personalize breast cancer treatment by enabling timely decisions about therapy modifications, potentially reducing unnecessary chemotherapy, minimizing side effects, and lowering healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer therapy: the role of PET-CT in decision making. Pons, F., Duch, J., Fuster, D.[2009]

Preoperative systemic therapy for breast cancer is increasingly personalized, with a focus on identifying predictive markers to improve patient outcomes, although only a small percentage achieve a pathologic complete response, which is the gold standard for treatment efficacy.

(18)F-fluorodeoxyglucose (FDG) PET imaging is shown to be more effective than traditional imaging methods for monitoring treatment response in breast cancer, potentially allowing for better treatment tailoring and reducing unnecessary side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radionuclide response assessment of breast cancer. Kostakoglu, L.[2016]

FDG-PET/CT is a highly accurate method for staging and evaluating response in metastatic breast cancer, showing greater sensitivity in detecting disease progression compared to conventional imaging methods like CT and bone scintigraphy.

Using FDG-PET/CT for monitoring treatment response has been associated with a survival benefit, as it allows for earlier detection of disease progression, leading to timely treatment adjustments that may enhance treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A role of FDG-PET/CT for response evaluation in metastatic breast cancer? Hildebrandt, MG., Naghavi-Behzad, M., Vogsen, M.[2022]

In a study of 108 breast cancer patients undergoing neoadjuvant chemotherapy, the baseline standardized uptake value (SUV) from FDG PET/CT scans was not a reliable predictor of pathological complete response (pCR) due to significant overlap between responders and non-responders.

However, a significant reduction in SUV (72.1% or greater) after four cycles of chemotherapy was associated with a high sensitivity (88.9%) and specificity (78.7%) for predicting pCR, indicating that monitoring changes in SUV can be a valuable tool in optimizing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-fluorodeoxyglucose positron emission tomography optimizes neoadjuvant chemotherapy for primary breast cancer to achieve pathological complete response. Ueda, S., Saeki, T., Shigekawa, T., et al.[2021]

FDG-PET is not accurate enough to rule out the presence of small primary breast tumors or to detect axillary lymph node metastases, requiring additional methods like sentinel node biopsy for confirmation.

The technique is also insufficient for assessing chemotherapy response due to a lack of standardized criteria, meaning it cannot reliably indicate the absence of residual disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of FDG-PET in breast cancer. Escalona, S., Blasco, JA., Reza, MM., et al.[2021]

In a prospective study assessing the impact of chemotherapy on FDG-PET imaging in colorectal cancer patients, it was found that preoperative chemotherapy significantly reduced tumor FDG uptake, making it harder to detect liver metastases.

The decrease in PET imaging accuracy was linked to a reduction in the activity of hexokinase, a key enzyme in glucose metabolism, suggesting that FDG-PET results should be interpreted with consideration of ongoing chemotherapy treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent chemotherapy reduces the sensitivity of [18F]fluorodeoxyglucose positron emission tomography in the detection of colorectal metastases. Akhurst, T., Kates, TJ., Mazumdar, M., et al.[2019]

Beyond (18)F-fluorodeoxyglucose (FDG), new PET radiopharmaceuticals are being researched to enhance breast cancer diagnosis and treatment, focusing on areas like tumor perfusion and receptor imaging.

Preliminary results in four key research areas—tumor perfusion, drug delivery, receptor imaging, and early response evaluation—show promise in improving treatment selection for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast Cancer Imaging with Novel PET Tracers. Mankoff, DA., Lee, JH., Eubank, WB.[2016]

FDG-PET imaging provides a non-invasive way to assess tumor metabolism, allowing for the quantification of glucose utilization in tumors, which helps differentiate between benign and malignant lesions.

Clinical studies indicate that serial FDG-PET scans can predict early responses to chemotherapy in breast cancer and lymphoma, aiding in treatment decisions and potentially avoiding ineffective therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative assessment of tumor metabolism using FDG-PET imaging. Weber, WA., Schwaiger, M., Avril, N.[2019]

Fluorine-18 fluorodeoxyglucose positron emission tomography (FDG-PET) shows a pooled sensitivity of 80.5% and specificity of 78.8% in monitoring breast cancer responses to neoadjuvant chemotherapy, based on a systematic review of 15 studies involving 745 patients.

FDG-PET can effectively differentiate between responders and nonresponders to chemotherapy early in treatment, with sensitivity increasing to 82.4% after two courses of chemotherapy, indicating its potential utility in clinical decision-making for breast cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorine-18 fluorodeoxyglucose positron emission tomography-computed tomography in monitoring the response of breast cancer to neoadjuvant chemotherapy: a meta-analysis. Mghanga, FP., Lan, X., Bakari, KH., et al.[2015]

References

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

Positron emission tomography using [(18)F]Fluorodeoxyglucose for monitoring primary chemotherapy in breast cancer. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Breast cancer therapy: the role of PET-CT in decision making. [2009]

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

Radionuclide response assessment of breast cancer. [2016]

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

A role of FDG-PET/CT for response evaluation in metastatic breast cancer? [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

18F-fluorodeoxyglucose positron emission tomography optimizes neoadjuvant chemotherapy for primary breast cancer to achieve pathological complete response. [2021]

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

A systematic review of FDG-PET in breast cancer. [2021]

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

Recent chemotherapy reduces the sensitivity of [18F]fluorodeoxyglucose positron emission tomography in the detection of colorectal metastases. [2019]

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

Breast Cancer Imaging with Novel PET Tracers. [2016]

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

Quantitative assessment of tumor metabolism using FDG-PET imaging. [2019]

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

Fluorine-18 fluorodeoxyglucose positron emission tomography-computed tomography in monitoring the response of breast cancer to neoadjuvant chemotherapy: a meta-analysis. [2015]