FDG-PET/CT Assessment for Breast Cancer

Not currently recruiting at 121 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: ECOG-ACRIN Cancer Research Group

Must be taking: Endocrine therapy, HER2-targeted therapy

Disqualifiers: Viscera lesions, CNS disease, 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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how effectively a special imaging test, called FDG-PET/CT, can track breast cancer activity that has primarily spread to the bones. The goal is to determine if this imaging method better reveals changes in the cancer before and after treatment compared to other scans. This trial suits individuals with breast cancer that has spread to the bones, who plan to begin new systemic therapy (such as hormone therapy or chemotherapy), and can safely undergo FDG-PET/CT imaging. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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

The trial does not specify that you need to stop your current medications. However, if you are using colony stimulating growth factors, you must stop them at least 14 days before the FDG-PET/CT scans. Bone-stabilizing agents like bisphosphonates or denosumab are allowed.

What prior data suggests that FDG-PET/CT is safe for assessing breast cancer?

Research has shown that FDG-PET/CT scans are generally well-tolerated by breast cancer patients. Fludeoxyglucose F-18, the substance used in these scans, is safe for most people, with few reports of serious side effects.

Studies have found that FDG-PET/CT effectively diagnoses and monitors breast cancer without causing significant discomfort or harm. Patients receive a small amount of Fludeoxyglucose F-18 through an IV before the scan, which helps doctors see cancer activity in the body.

Overall, research suggests that this procedure is safe and provides valuable insights into the effectiveness of cancer treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about FDG-PET/CT for breast cancer because it offers a more precise way to assess how well a treatment is working. Unlike traditional imaging techniques, FDG-PET/CT combines two powerful technologies: positron emission tomography (PET) and computed tomography (CT), using a special radioactive sugar called Fludeoxyglucose F-18. This combination allows doctors to see detailed images of the cancer and how active it is, potentially enabling them to tailor treatments more effectively. While standard imaging methods mainly show the size and shape of tumors, FDG-PET/CT provides insights into the tumor's metabolism and response to therapy. This could lead to more personalized and timely adjustments in treatment plans, improving outcomes for patients.

What evidence suggests that FDG-PET/CT is effective for assessing bone-dominant metastatic breast cancer?

Studies have shown that FDG-PET/CT, which participants in this trial will undergo, effectively detects breast cancer that has spread to the bones. It helps doctors assess how well the cancer responds to treatment. Research indicates that this imaging method can significantly influence treatment decisions by providing clear and accurate images of cancer activity. In some cases, FDG-PET/CT surpasses other imaging tests in tracking the spread of breast cancer, giving doctors greater confidence in managing the disease. ^{3 6 7 8 9}

Who Is on the Research Team?

Jennifer M. Specht

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

This trial is for patients with breast cancer that has spread to the bones. Participants must have a life expectancy of at least 24 weeks, an ECOG performance status of <=2, and meet renal function guidelines. They should plan to receive specific systemic therapies like endocrine therapy or chemotherapy. Pregnant or breastfeeding women, those with certain other cancers or who've had extensive chemotherapy are excluded.

Inclusion Criteria

My breast cancer has spread, is hormone receptor positive, and my HER2 status is known.

I am planning or currently receiving specific treatments for my metastatic breast cancer.

My kidney function is good enough for MRI and CT scans.

Exclusion Criteria

My cancer has not spread to my brain, membranes around the brain and spine, or filled my chest or abdomen cavities.

Patients currently participating in or have participated in a study of an investigational agent or using an investigational device within 3 weeks of study registration are not eligible

I have not had more than 3 chemotherapy treatments for my advanced breast cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

1 visit (in-person)

Baseline Assessment

Participants receive FDG intravenously and undergo PET/CT scan over 15-30 minutes at baseline

1 day

1 visit (in-person)

Treatment

Participants undergo standard systemic treatment and a follow-up PET/CT scan at 12 weeks

12 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

Periodic visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Computed Tomography
• Fludeoxyglucose F-18
• Positron Emission Tomography

Trial Overview The FEATURE study is testing how well FDG-PET/CT scans measure activity in bone-dominant metastatic breast cancer before and after treatment compared to standard imaging tests. This phase II trial aims to improve diagnostic accuracy for assessing responses in these patients.

How Is the Trial Designed?

Group I: Diagnostic (FDG-PET/CT) Experimental Treatment 3 Interventions

Patients receive FDG IV and undergo PET/CT scan over 15-30 minutes at baseline (within 21 days before start of standard systemic treatment) and at 12 weeks after start of standard systemic treatment in the absence of unacceptable toxicity.

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials

122

Recruited

160,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

This study highlights the first reported case of an allergic reaction to fluorodeoxyglucose, a radiopharmaceutical used in PET/CT scans, in a patient undergoing repeated scans for pyriform sinus cancer.

As the use of PET/CT procedures increases, it is crucial to understand and manage potential adverse effects, such as allergic reactions, to ensure patient safety during these diagnostic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorodeoxyglucose-induced allergic reaction: a case report. Codreanu, I., Dasanu, CA., Weinstein, GS., et al.[2019]

FDG-PET/CT is an effective imaging tool that combines metabolic and anatomical data, enhancing the diagnosis and management of breast cancer and other tumors in a single session.

This imaging technique is valuable for various stages of cancer management, including diagnosis, staging, treatment response assessment, and evaluating metastatic disease, although it also has some limitations that need to be considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Present and future role of FDG-PET/CT imaging in the management of breast cancer. Kitajima, K., Miyoshi, Y.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12354408/

Comparing the diagnostic efficacy of [18F]FDG PET/CT and ... This meta-analysis evaluates and compares the diagnostic accuracy of [18F]FDG PET/CT and [18F]FDG PET/MRI in detecting breast cancer ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10378166/

Influence of [18F]FDG-PET/CT on Clinical Management ... This study shows that PET/CT significantly impacts clinical management decisions in breast cancer patients in different clinical scenarios, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526820924002726

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 ...

4. facs.org facs.org/for-medical-professionals/news-publications/news-and-articles/bulletin/2024/julyaugust-2024-volume-109-issue-7/18f-fdg-petct-in-early-stage-breast-cancer-comes-with-financial-burden/

18F-FDG PET/CT in Early Stage Breast Cancer Comes ... In 22 patients whose 18F-FDG PET/CT scans showed distant metastasis, 45.5% were luminal type, 50% were HER2-positive, and only one patient was ...

5. jnm.snmjournals.org jnm.snmjournals.org/content/57/Supplement_1/17S

18F-FDG PET/CT for Staging and Restaging of Breast ... This review assesses the advantages and limits of 18 F-FDG PET/CT in initial staging and restaging for breast cancer patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9955497/

The Role of PET/CT in Breast Cancer - PMC - PubMed Central The role of 18F-FDG PET/CT in breast cancer is in diagnosis, staging, prognosis, treatment response evaluation, radiotherapy planning, and detection of ...

7. medicaljournalssweden.se medicaljournalssweden.se/actaoncologica/article/view/40003

18F-FDG-PET/CT in breast cancer imaging The impact of 18F-FDG-PET/CT-scans on clinical management was categorized as no change, minor change (e.g. modification of treatment plans), or ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0899707124000305

Value of 18F-FDG PET/CT in breast cancer with second ... Applying 18 F-FDG PET/CT in BC patients might be helpful in detecting SPMs and partially predicting patient prognosis, in addition to its primary function in ...

9. ejhi.springeropen.com ejhi.springeropen.com/articles/10.1186/s41824-023-00176-3

Head-to-head comparison of 18F-FDG and 18F-FES PET/CT ... This study aimed to compare the diagnostic performance of 18 F-FDG and 18 F-FES PET/CT in the initial staging of ER-positive breast cancer.