FDG-PET/CT Scan Prediction for Breast Cancer

Recruiting at 93 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special imaging test called FDG-PET/CT can help doctors predict the response of breast cancer patients to chemotherapy before surgery. The focus is on patients with HER2-positive breast cancer, a type where a protein promotes cancer growth. The goal is to determine if this imaging test can tailor treatment plans for the best outcomes. Patients diagnosed with untreated HER2-positive breast cancer who plan to start chemotherapy might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing valuable insights for participants.

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 prior data suggests that FDG-PET/CT is safe for predicting chemotherapy response in breast cancer patients?

Research has shown that Fludeoxyglucose F-18 (FDG) is generally safe as a diagnostic tool. FDG, a radioactive substance, is used in PET/CT scans to identify active cancer areas. Safety data from 374 patients indicates that most people tolerate it well. However, due to its radiation, there is a small risk of increased cancer risk, particularly in children. In adults, it is considered safe when used in the smallest necessary amounts. Overall, FDG is trusted in medical settings to assist doctors in making important treatment decisions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how FDG-PET/CT scans can predict the effectiveness of chemotherapy in breast cancer treatment. Unlike standard imaging techniques, FDG-PET/CT scans provide a detailed view of metabolic activity within tumors, potentially identifying how well a tumor is responding to treatment earlier than traditional methods. This early insight could help doctors tailor treatment plans more effectively, ensuring patients receive the most appropriate care sooner. By potentially optimizing treatment paths, this approach aims to improve outcomes and minimize unnecessary side effects for patients.

What evidence suggests that FDG-PET/CT is effective for predicting chemotherapy response in breast cancer?

Research has shown that FDG-PET/CT scans, which participants in this trial will undergo, effectively predict breast cancer's response to chemotherapy. In studies, this imaging method correctly identified cancer recurrence in 93 out of 100 cases. The scan uses a small amount of radioactive material to highlight active cancer areas, aiding doctors in making better treatment decisions. It has proven especially useful in predicting when treatment will completely eliminate the cancer. This suggests FDG-PET/CT could be a valuable tool for personalizing breast cancer treatments. ^{6 7 8 9 10}

Who Is on the Research Team?

Heather Jacene

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

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Role of 18F-fluorodeoxyglucose positron emission ... Complete responses were observed in 16 patients (37%) with CI and 34 patients (72%) with 18F-FDG PET. The 18F-FDG PET result was the most powerful and ...

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Review Article Comparison of [ 18 F] FDG PET/CT and ... This meta-analysis aims to assess and compare the diagnostic effectiveness of [ 18 F]FDG PET/CT and [ 18 F]FDG PET/MRI for distant metastases in breast cancer ...

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Comparing the diagnostic efficacy of [18F]FDG PET/CT and ... In diagnosing recurrence in breast cancer at the patient level, [18F]FDG PET/CT demonstrated a pooled sensitivity of 0.93 (95% CI: 0.88–0.96), ...

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Fluoroestradiol (FES) and Fluorodeoxyglucose (FDG) PET ... F-Fluorodeoxyglucose (FDG) and 18F-Fluorestradiol (FES) have been FDA approved for measuring tumor glycolytic activity and estrogen receptor (ER) ...

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Testing The Role Of FDG-PET/CT To Predict Response To ... The purpose of this study is to test how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed ...

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Fludeoxyglucose (18F) - StatPearls - NCBI Bookshelf - NIH Fludeoxyglucose F18 is a radioactive tracer that acts as a glucose analog and is used for diagnostic purposes in conjunction with positron-emitting tomography ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2005/021870lbl.pdf

Fludeoxyglucose F 18 Injection - accessdata.fda.gov All these studies had at least 50 patients and used pathology as a standard of truth to compare the results of PET imaging with Fludeoxyglucose F 18 Injection.

8. rxlist.com rxlist.com/fludeoxyglucose-drug.htm

Fludeoxyglucose F 18 Injection (FDG): Side Effects, Uses, ... Side Effects for Fludeoxyglucose F 18 Injection. The [18F]FDG safety data base was evaluated for 374 patients. Of these, 245 were male and 105 were female ...

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Fludeoxyglucose F 18 Injection - accessdata.fda.gov Radiation-emitting products, including Fludeoxyglucose F 18 Injection, may increase the risk for cancer, especially in pediatric patients. Use the smallest ...

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Benefits and harms of implementing [18F]FDG-PET/CT for ... Metastatic breast cancer (MBC) has a poor prognosis with a five-year survival of 25% [1, 2]. Detection of distant metastases is important for ...