---
title: Clinical Utility of FES F18 PET/CT in Metastatic Breast Cancer Patients
nct_id: NCT05068726
overall_status: TERMINATED
sponsor: GE Healthcare
study_type: OBSERVATIONAL
primary_condition: Metastatic Breast Cancer
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05068726.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05068726"
ct_last_update_post_date: 2024-07-31
last_seen_at: "2026-05-12T06:45:33.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Clinical Utility of FES F18 PET/CT in Metastatic Breast Cancer Patients

**Official Title:** Clinical Utility of Fluoroestradiol F18 PET/CT in Metastatic Breast Cancer Patients With ER-Positive and HER2-Negative Primary Lesions After Progression on First Line Hormonal Therapy

**NCT ID:** [NCT05068726](https://clinicaltrials.gov/study/NCT05068726)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Sponsor discretion (low recruitment rate)
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 51
- **Lead Sponsor:** GE Healthcare
- **Collaborators:** Simbec-Orion Group, Medpace, Inc., Zionexa
- **Conditions:** Metastatic Breast Cancer
- **Start Date:** 2023-01-05
- **Completion Date:** 2024-06-01
- **CT.gov Last Update:** 2024-07-31

## Brief Summary

This is a phase 4, multi-center, open-label, prospective cohort study to evaluate the clinical utility of Fluoroestradiol F18 (Cerianna) PET/CT to guide therapeutic management in ER-positive, HER2-negative metastatic breast cancer patients with progressive disease on first-line standard-of-care hormonal therapy. All patients will undergo a Cerianna PET/CT scan. The treating physician will complete a standardized questionnaire to indicate the second-line therapeutic management plan before the scheduled Cerianna PET/CT. After interpretation of Cerianna PET/CT by local radiologist or nuclear medicine physician, the treating physician will fill out a similar questionnaire to specify the final therapeutic decision. The proportion of patients with a change in therapeutic management plan based on Cerianna PET/CT results will be the primary endpoint. During the study follow-up period of 18 months, data on standard-of-care imaging, treatments/procedures received, and clinical outcomes will be collected. Patients will be asked to complete a health-related quality of life questionnaire at their screening, 6-month, and 18-month visit. Secondary endpoints include visual and quantitative heterogeneity assessment of tumor Cerianna uptake, and PFS rates at 6 months and 18 months after Cerianna PET/CT, which will be assessed between patients with and without a change in therapeutic management plan. Maximum duration of follow-up for each patient: 20 months. First patient first visit to last patient last visit: estimated 36 months.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 99 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patient must sign informed consent prior to enrollment in this trial
* The patient is a female ≥18 years old
* Post-menopausal or pre-menopausal patient with known primary breast tumor(s) expressing ER in ≥1% of tumor cells by IHC
* HER2-negative (0, 1+, 2+ fluorescence in situ hybridization (FISH) negative) primary lesion
* MBC with at least 1 identifiable lesion on standard-of-care imaging assessment, outside of the liver, as confirmed by the investigator site
* Patient with progressive disease on 1st line hormonal therapy (Aromatase Inhibitor) with or without a CDK4/6 inhibitor or mechanistic target of rapamycin (mTOR) inhibitor or phosphoinositide 3-kinases (PI3K) inhibitor
* Patient must score at least 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status
* Life expectancy of at least 12 months
* The patient is planned to undergo a standard-of-care imaging scan (according to National Comprehensive Cancer Network guidelines, e.g., CT and/or bone scan, or fluorodeoxyglucose \[FDG\]-PET/CT) covering chest, abdomen, and pelvis after date of consent and before Cerianna PET/CT (Visit 2), or the patient has undergone recent standard-of-care imaging before date of consent and is planned to undergo Cerianna PET/CT (Visit 2) no more than 45 days from the standard-of-care imaging scan

Exclusion Criteria:

* Isolated hepatic metastases (taking into account the physiological hepatic high uptake of Cerianna)
* Patient is on tamoxifen/toremifene treatment without 8-week washout, or on fulvestrant treatment without 28-week washout, (may block ER) before Cerianna PET/CT
* Other evolutive malignant disease (non-melanoma skin cancer is allowed) or acute or chronic infectious disease (well-controlled infectious disease is allowed);
* Patient has a history of administered chemotherapy for metastatic disease; prior chemotherapy in the (neo)adjuvant setting is allowed
* Patient with a known allergy to any of the components of Cerianna
* Woman of childbearing age who is not using effective contraception
* Pregnant woman (per the Product Label and ensured using clinic's standard-of-care), or parturient or nursing mother
* Patient presents with any other clinically active, serious, life-threatening disease, medical, or psychiatric condition, and/or who has a life expectancy of \<12 months, or for whom study participation may compromise their management; and/or a patient who the investigator judges to be unsuitable for participation in the study for any reason
* Inability to comply with any requirements of the protocol
```

## Interventions

- **18F Fluoroestradiol Radiopharmaceutical with PET/CT** (DRUG) — Administration of one dose of 18F FES for PET/CT imaging

## Primary Outcomes

- **Evaluate change in therapeutic management plan assessed by comparing pre/post-Cerianna PET/CT treatment selection (based on comparison of the initial management plan and post-Cerianna PET/CT management plan evaluated within 3 weeks).** _(time frame: [Time Frame: Baseline and within 3 weeks after Cerianna PET/CT)_ — The percentage of subjects with changes in the therapeutic management plan after Cerianna PET/CT with 95% confidence interval will be estimated by comparison of the initial management plan vs. the post-Cerianna PET/CT management plan evaluated within 3 weeks after Cerianna PET/CT.

## Secondary Outcomes

- **Number and percentage of lesions detected with Cerianna PET/CT (focal Cerianna uptake, outside the liver, visible above background) in individual patients.** _(time frame: Time Frame: Baseline, Cerianna PET/CT)_
- **SUV** _(time frame: Time Frame: Baseline, Cerianna PET/CT)_
- **Heterogeneity** _(time frame: Time Frame: baseline Cerianna PET/CT and within 3 weeks after Cerianna PET/CT)_
- **Confidence** _(time frame: Time Frame: baseline and within 3 weeks after Cerianna PET/CT)_
- **Change in management** _(time frame: Timeframe: baseline, 6 months and 18 months after Cerianna PET/CT)_
- **PFS** _(time frame: Timeframe: baseline, 6 months and 18 months after Cerianna PET/CT)_

## Locations (24)

- Northern Arizona Healthcare, Flagstaff, Arizona, United States
- TOI Clinical Research, Cerritos, California, United States
- City of Hope Comprehensive Cancer Center, Duarte, California, United States
- Long Beach Memorial Medical Center, Long Beach, California, United States
- University of Southern California, Los Angeles, California, United States
- Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
- PET/CT Imaging of San Jose, San Jose, California, United States
- Providence Saint John's Health Center, Santa Monica, California, United States
- Valley Breast Care, Van Nuys, California, United States
- Tampa General Hospital Cancer Institute, Tampa, Florida, United States
- Emory University, Atlanta, Georgia, United States
- MD Clinics, Shreveport, Louisiana, United States
- Icahn School of Medicine at Mount Sinai, New York, New York, United States
- The New York Presbyterian Hospital-Columbia University Medical Center, New York, New York, United States
- WakeMed, Cary, North Carolina, United States
- Duke University, Durham, North Carolina, United States
- Kettering Health Cancer Center, Kettering, Ohio, United States
- St. Luke's University Health Network, Allentown, Pennsylvania, United States
- University of Pennsylvania / Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States
- Magee-Womens Hospital of UPMC, Pittsburgh, Pennsylvania, United States
- Baylor Research Institute d/b/a Baylor Scott & White Research Institute, Dallas, Texas, United States
- University of Virginia, Charlottesville, Virginia, United States
- Blue Ridge Cancer Care, Roanoke, Virginia, United States
- Fred Hutchinson Cancer Center, Seattle, Washington, United States

## Recent Field Changes (last 30 days)

- `locations.md clinics|shreveport|louisiana|united states` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.northern arizona healthcare|flagstaff|arizona|united states` — added _(2026-05-12)_
- `locations.toi clinical research|cerritos|california|united states` — added _(2026-05-12)_
- `locations.city of hope comprehensive cancer center|duarte|california|united states` — added _(2026-05-12)_
- `locations.long beach memorial medical center|long beach|california|united states` — added _(2026-05-12)_
- `locations.university of southern california|los angeles|california|united states` — added _(2026-05-12)_
- `locations.hoag memorial hospital presbyterian|newport beach|california|united states` — added _(2026-05-12)_
- `locations.pet/ct imaging of san jose|san jose|california|united states` — added _(2026-05-12)_
- `locations.providence saint john's health center|santa monica|california|united states` — added _(2026-05-12)_
- `locations.valley breast care|van nuys|california|united states` — added _(2026-05-12)_
- `locations.tampa general hospital cancer institute|tampa|florida|united states` — added _(2026-05-12)_
- `locations.emory university|atlanta|georgia|united states` — added _(2026-05-12)_
- `locations.icahn school of medicine at mount sinai|new york|new york|united states` — added _(2026-05-12)_
- `locations.the new york presbyterian hospital-columbia university medical center|new york|new york|united states` — added _(2026-05-12)_
- `locations.wakemed|cary|north carolina|united states` — added _(2026-05-12)_
- `locations.duke university|durham|north carolina|united states` — added _(2026-05-12)_
- `locations.kettering health cancer center|kettering|ohio|united states` — added _(2026-05-12)_
- `locations.st. luke's university health network|allentown|pennsylvania|united states` — added _(2026-05-12)_
- `locations.university of pennsylvania / perelman center for advanced medicine|philadelphia|pennsylvania|united states` — added _(2026-05-12)_
- `locations.magee-womens hospital of upmc|pittsburgh|pennsylvania|united states` — added _(2026-05-12)_
- `locations.baylor research institute d/b/a baylor scott & white research institute|dallas|texas|united states` — added _(2026-05-12)_
- `locations.university of virginia|charlottesville|virginia|united states` — added _(2026-05-12)_
- `locations.blue ridge cancer care|roanoke|virginia|united states` — added _(2026-05-12)_
- `locations.fred hutchinson cancer center|seattle|washington|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05068726.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05068726*  
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