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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06086704




Registration number
NCT06086704
Ethics application status
Date submitted
11/10/2023
Date registered
17/10/2023

Titles & IDs
Public title
Study of 18F-FFNP Breast PET/MRI
Scientific title
Phase II Study of 18F-FFNP Breast PET/MRI in the Assessment of Early Response of Breast Cancer to Presurgical Endocrine Therapy
Secondary ID [1] 0 0
Protocol Version 7/13/2023
Secondary ID [2] 0 0
2023-1114
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 18F-fluorofuranylnorprogesterone
Treatment: Devices - Positron Emissions Tomography / Magnetic Resonance Imaging
Treatment: Drugs - Anastrozole
Other interventions - Blood Sampling
Treatment: Drugs - Gadobenate dimeglumine

Experimental: Group 1: Metabolite Analysis - participants will undergo venous blood sampling during the PET/MRI scan

Experimental: Group 2: Pre-surgical Treatment - participants will undergo PET/MRI scans before and after 2 weeks treatment with anastrozole

Experimental: Group 3: Test-Retest - participants will undergo baseline and repeat PET/MRI scans without intervening treatment to determine repeatability


Treatment: Drugs: 18F-fluorofuranylnorprogesterone
18F-FFNP will be given by a slow infusion (approximately 2 minutes), and the dose administered will be approximately 7 mCi.

Treatment: Devices: Positron Emissions Tomography / Magnetic Resonance Imaging
Breast specific PET/MRI data will be acquired using a 3T simultaneous PET/MRI scanner (Signa PET/MR, GE Healthcare)

Treatment: Drugs: Anastrozole
hormone based chemotherapy that reduces estrogen, 1 mg anastrozole once daily by mouth for a minimum of 14 days

Other interventions: Blood Sampling
Venous blood samples will be collected at multiple timepoints (e.g., 5, 10, 20, 30, and 45 min after 18F-FFNP injection to determine parent and metabolite fractions

Treatment: Drugs: Gadobenate dimeglumine
FDA-approved gadolinium-based intravenous contrast agent used for the MRI portion of this study
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage change in 18F-FFNP uptake between baseline and follow-up PET/MRI scans
Timepoint [1] 0 0
up to 4 weeks on study and up to 7 weeks on study
Primary outcome [2] 0 0
Percentage change in tumor Ki67 proliferation score, as a surrogate measure of endocrine sensitivity
Timepoint [2] 0 0
up to 4 weeks on study and up to 7 weeks on study
Secondary outcome [1] 0 0
Qualitative Analysis of 18F-FFNP uptake
Timepoint [1] 0 0
imaging takes up to 2 hours during a visit and will take place up to 4 weeks and up to 6 weeks for the test-retest Group 3
Secondary outcome [2] 0 0
Intra- and Inter-Observer Variability of Quantitative Assessment of Tumor 18F-FFNP uptake
Timepoint [2] 0 0
imaging takes up to 2 hours during a visit and will take place up to 4 weeks and up to 6 weeks for the test-retest Group 3
Secondary outcome [3] 0 0
Quantitative Assessment of Tumor 18F-FFNP: Standardized Uptake Values (SUV)
Timepoint [3] 0 0
imaging takes up to 2 hours during a visit and will take place up to 4 weeks and up to 6 weeks for the test-retest Group 3
Secondary outcome [4] 0 0
Test-Retest Variability of Quantitative Assessment of Tumor 18F-FFNP uptake
Timepoint [4] 0 0
imaging takes up to 2 hours during a visit and will take place up to 4 weeks and up to 6 weeks for the test-retest Group 3
Secondary outcome [5] 0 0
NCIC Adverse Events Version 5.0 Frequency Tables
Timepoint [5] 0 0
up to 7 weeks

Eligibility
Key inclusion criteria
* Postmenopausal status defined by either

* prior bilateral oophorectomy
* age greater than or equal to 60 years of age
* age less than 60 years of age and amenorrheic for 12 or more months in the absence of prior chemotherapy, tamoxifen, toremifene or ovarian suppression and FSH and estradiol in the postmenopausal range per local normal range
* Diagnosis of biopsy-proven invasive breast cancer measuring at least 1.0 cm in diameter by any imaging modality
* Biopsy-proven ER-positive, PR-positive, HER2-negative invasive breast cancer
* Breast MRI planned or performed before surgery
* Definitive surgical excision of the primary tumor planned without neoadjuvant therapy; defined as therapy (chemotherapy, targeted therapy, radiation therapy or endocrine therapy) given to decrease the size of the tumor prior to planned surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Inability or unwillingness to provide informed consent to the study
* PR and Ki67 IHC slides or FFPE tissue blocks from clinical breast biopsy not available
* Patients who have completed neoadjuvant chemotherapy, endocrine therapy, targeted therapy, surgical resection, or radiation for the current biopsy-proven malignancy
* Patients who are planning to undergo anastrozole as standard of care neoadjuvant therapy
* Patients who are currently taking aromatase inhibitors or ER antagonists (tamoxifen, raloxifene)
* Patients with breast expanders
* Patients who are pregnant or lactating
* Patients whose girth exceeds the bore of the PET/MRI scanner
* Patients with a contraindication to gadolinium-based contrast agents, including allergy or impaired renal function (per UW Health Guidelines)
* Patients with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FFNP
* Patients with history of allergic reaction to anastrozole
* Patients in liver failure as judged by the patient's physician
* Patients with standard contraindications to MRI (per UW Health Guidelines)
* Patients requiring conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the clinical MRI scan will be allowed to participate as long as the following criteria are met:

* The patient has their own prescription for the medication
* The informed consent process is conducted prior to the self-administration of the medication.
* The patient comes to the research visit with a driver.
* Patients unable to lie prone for 45 minutes for imaging
* Patients taking hormone replacement therapy or over-the-counter products/supplements/herbal preparation with potential estrogenic effects who are unwilling to discontinue these agents during the timeframe of the study until surgery.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2030
Actual
Sample size
Target
53
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Wisconsin

Funding & Sponsors
Primary sponsor type
Other
Name
University of Wisconsin, Madison
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amy M Fowler, MD, PHD
Address 0 0
UW Carbone Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Cancer Connect
Address 0 0
Country 0 0
Phone 0 0
800-622-8922
Fax 0 0
Email 0 0
clinicaltrials@cancer.wisc.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06086704