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FDG-PET/CT Assessment for Breast Cancer

Q: How many individuals are engaging in this medical research project?

To successfully launch this trial, 134 qualifying patients need to enroll. Those that meet the criteria can visit either <a href="https://www.withpower.com/clinical-trials/washington">Washington</a> University School of Medicine in Saint Louis or Siteman <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center at Christian Hospital in San Francisco for screening and treatment.

Q: What adverse effects are associated with administering Fludeoxyglucose F-18?

Fludeoxyglucose F-18 is regarded as safe in this Phase 2 trial, thus receiving a score of 2. This signifies that while safety data exists, no efficacy information has been gathered yet.

Q: In how many distinct areas is this research project actively taking place?

This clinical trial is enrolling participants at 81 sites, with locations in Saint Louis, San Francisco and Marshfield. Participants are encouraged to select the closest site to reduce travel demands associated with participation.

Q: Is there still an opportunity to enroll in this experiment?

Affirmative, according to clinicaltrials.gov this research project is recruiting participants now. It was published on April 2nd 2020 and has recently been updated on September 28th 2022. A total of 134 people are being sought out from 78 particular sites.

Phase 2

Waitlist Available

Led By Jennifer M Specht

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with histologically confirmed metastatic breast cancer by local assessment that is hormone receptor positive by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines and with known HER2 status

Patient must meet institutional guidelines for renal function for MRI and CT scanning

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years after study registration

Awards & highlights

Study Summary

This trial looks at how well FDG-PET/CT works in assessing the response of patients with bone-dominant metastatic breast cancer to treatment.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While this trial focuses on diagnostic procedures rather than treatments, FDG-PET/CT involves exposure to radiation which carries risks such as a very small increase in the chance of developing cancer later in life.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

My cancer is mainly in my bones.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years after study registration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years after study registration

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years after study registration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Performance of fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) response criteria as a binary predictor of progression-free survival (PFS)

Secondary outcome measures

Ability of FDG-PET/CT metrics to predict OS in patients with BD MBC

PET/CT scan

Ability of FDG-PET/CT metrics to predict time to SRE in patients with BD MBC

+4 more

Other outcome measures

Automated image analysis of FDG-PET/CT

Defining of criteria for selection of FDG-avid bone lesions for analysis based on thresholds for SULpeak or SUVmax

Exploration of alternative methods for measuring metabolic response with FDG-PET/CT to predict clinical endpoints in patients with BD MBC

Side effects data

From 2011 Phase 2 trial • 55 Patients • NCT00062374

65%

Fatigue

64%

Hypocalcemia

60%

Nausea

58%

White blood cell count decrease

56%

Neutrophil count decrease

55%

Hemoglobin decrease

45%

Diarrhea

38%

Platelet count decreased

36%

Hyponatremia

31%

Hypophosphatemia

29%

Anorexia

29%

Hypokalemia

27%

Abdominal pain/cramping

22%

Hypomagnesemia

22%

Vomiting

20%

Hyperglycemia

20%

Hyperkalemia

20%

Lymphocyte count decrease

20%

Neuropathy-sensory

20%

Hypoalbuminemia

18%

Alanine aminotransferase increase

13%

Dyspnea

13%

Aspartate aminotransferase increase

11%

Creatinine

11%

Dehydration

11%

Dizziness

11%

Edema

Thrombosis

Alopecia

Hypernatremia

Weight loss

Hearing impaired

Constipation

Dyspepsia

Mood alteration/anxiety

Taste disturbance

Febrile neutropenia

Dysphagia

Pain, other

Hypoglycemia

Pharyngeal mucositis

Hemorrhage, NOS

CNS/cerebrovascular ischemia

Chest pain

Gastrointestinal disorder

Cardiovascular, other

Seizure

Hypotension

Muscle weakness

Creatinine increased

100%

80%

60%

40%

20%

Study treatment Arm

Arm I

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (FDG-PET/CT)Experimental Treatment3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2720

Positron Emission Tomography

2008

Completed Phase 2

~2240

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor

116 Previous Clinical Trials

176,784 Total Patients Enrolled

4 Trials studying Breast Cancer

3,528 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,529 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Jennifer M SpechtPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Fludeoxyglucose F-18 Clinical Trial Eligibility Overview. Trial Name: NCT04316117 — Phase 2

Breast Cancer Research Study Groups: Diagnostic (FDG-PET/CT)

Breast Cancer Clinical Trial 2023: Fludeoxyglucose F-18 Highlights & Side Effects. Trial Name: NCT04316117 — Phase 2

Fludeoxyglucose F-18 2023 Treatment Timeline for Medical Study. Trial Name: NCT04316117 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are engaging in this medical research project?

"To successfully launch this trial, 134 qualifying patients need to enroll. Those that meet the criteria can visit either Washington University School of Medicine in Saint Louis or Siteman Cancer Center at Christian Hospital in San Francisco for screening and treatment."

Answered by AI

What adverse effects are associated with administering Fludeoxyglucose F-18?

"Fludeoxyglucose F-18 is regarded as safe in this Phase 2 trial, thus receiving a score of 2. This signifies that while safety data exists, no efficacy information has been gathered yet."

Answered by AI

In how many distinct areas is this research project actively taking place?

"This clinical trial is enrolling participants at 81 sites, with locations in Saint Louis, San Francisco and Marshfield. Participants are encouraged to select the closest site to reduce travel demands associated with participation."

Answered by AI

Is there still an opportunity to enroll in this experiment?

"Affirmative, according to clinicaltrials.gov this research project is recruiting participants now. It was published on April 2nd 2020 and has recently been updated on September 28th 2022. A total of 134 people are being sought out from 78 particular sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Using FDG-PET/CT to Assess Response of Bone-Dominant Metastatic Breast Cancer, FEATURE Study

2020. "Using FDG-PET/CT to Assess Response of Bone-Dominant Metastatic Breast Cancer, FEATURE Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04316117.

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