FDG-PET/CT Assessment for Breast Cancer

Recruiting at 111 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

138 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how well certain scans work in assessing the response of patients with breast cancer that has spread to the bones. The scans use a special substance to highlight active cancer areas on detailed body images, helping doctors see if the treatment is working. These scans have been used successfully for various stages and evaluations of breast cancer.

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 data supports the effectiveness of the treatment FDG-PET/CT for breast cancer?

FDG-PET/CT is effective in managing breast cancer by providing both metabolic and anatomical imaging, which helps in diagnosis, staging, and monitoring treatment response. It is particularly useful for detecting distant metastases and recurrences, offering advantages over conventional imaging methods. ^{1 2 3 4 5}

Is FDG-PET/CT generally safe for humans?

FDG-PET/CT is generally considered safe, but it involves exposure to radiation, which can have health risks. There have been rare reports of allergic reactions to the radiopharmaceutical used in these scans. ^{6 7 8 9 10}

How does FDG-PET/CT treatment differ from other breast cancer treatments?

FDG-PET/CT is unique because it combines metabolic and anatomical imaging in one session, allowing for early detection of abnormal metabolic activity in breast cancer before physical changes occur. It is particularly useful for detecting distant metastases and monitoring treatment response, although it is not recommended as a primary diagnostic tool for small or well-differentiated tumors. ^{4 5 11 12 13}

Research Team

Jennifer M. Specht

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Risk stratification in patients with advanced-stage breast cancer by pretreatment [(18) F]FDG PET/CT. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The utility of 18 F-FDG PET/CT for suspected recurrent breast cancer: impact and prognostic stratification. [2018]

3. Japan pubmed.ncbi.nlm.nih.gov

PET/CT supports breast cancer diagnosis and treatment. [2016]

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

FDG PET/CT for the detection and evaluation of breast diseases: usefulness and limitations. [2016]

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

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

6. England pubmed.ncbi.nlm.nih.gov

Fluorodeoxyglucose-induced allergic reaction: a case report. [2019]

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

F-18 FDG uptake in breast infection and inflammation. [2019]

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

Radiation safety with positron emission tomography and computed tomography. [2015]

9. Germany pubmed.ncbi.nlm.nih.gov

Radiation exposure and mortality risk from CT and PET imaging of patients with malignant lymphoma. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Feasibility, Safety and Impact of (18F)-FDG PET/CT in patients with pregnancy-associated cancer: experience of the French CALG (Cancer Associé à La Grossesse) network. [2022]

11. Denmark pubmed.ncbi.nlm.nih.gov

Utility of 18FDG-PET/CT in breast cancer diagnostics--a systematic review. [2018]

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

FDG-PET Dynamic Contrast-Enhanced CT in the Management of Breast Cancer. [2016]

13. Egypt pubmed.ncbi.nlm.nih.gov

Molecular Imaging in Breast Cancer: From Whole-Body PET/CT to Dedicated Breast PET. [2021]