NCT04276272

Brief Summary

The aim of this study is to evaluate the effect of CDK4/6 inhibitor treatment on the tumour choline metabolism as determined by \[18F\]D4-FCH PET/ computed tomography(CT) in breast cancer and to determine the suitability of \[18F\]D4-FCH-PET/CT as a non-invasive, early imaging biomarker for therapy response following CDK4/6 inhibitor treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
2 years until next milestone

Study Start

First participant enrolled

February 24, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2023

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

1.7 years

First QC Date

February 17, 2020

Last Update Submit

August 23, 2024

Conditions

HER2-negative Breast CancerER Positive Breast CancerMetastatic Breast Cancer

Keywords

PET/CT

Outcome Measures

Primary Outcomes (1)

  • The change in tumour uptake of [18F]D4-FCH (standardized uptake at 60 min, fractional retention) after approximately 4-6 weeks of CDK4/6 inhibitor-based therapy in patients with locally advanced or metastatic breast cancer

    PET/CT

    Through scan completion 4-6 weeks

Secondary Outcomes (2)

  • Semi-quantitative assessment of the effect of CDK4/6 inhibitor-based therapy on [18F]D4-FCH tumour and normal tissue dynamics. Uptake of [18F]D4-FCH in normal tissues, and tumour target and non-target lesions combined (dynamic/whole body scans)

    Through study completion, an average 2.5 years

  • Correlation of [18F]D4-FCH uptake with tumour size or FDG-PET or appropriate standard clinical imaging

    Through study completion, an average 2.5 years

Interventions

Imaging scanOTHER

PET/CT scan

Also known as: [18F]D4-FCH-PET/CT

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

16 participants with HER2 negative/ER positive metastatic breast cancer who will be having CDK 4/6 inhibitor/endocrine therapy

You may qualify if:

  • Female patients with a histological diagnosis of locally advanced or metastatic estrogen-receptor positive, HER2 negative breast cancer
  • Written informed consent prior to admission in the study.
  • Target lesion diameter of ≥15mm that has not been previously irradiated and is located outside the liver
  • Female patients aged ≥ 18 years of age
  • For all patients: histologically confirmed locally advanced/ metastatic breast cancer with a previous biopsy confirming hormone receptor and HER2 status
  • ECOG performance status 0-2
  • Negative urine pregnancy test (within 2 hours prior to injection of imaging agent) in women of child bearing age and willingness to use contraception (barrier, abstinence, non-hormonal) for 3 weeks after injection of \[18F\]D4-FCH
  • Life expectancy \> 3months
  • Adequate organ function as judged by investigator to include:
  • Hb≥ 10g/L
  • Creatinine clearance ≥45ml/min
  • Patients must have been appropriately staged (which may include contrast enhanced CT/ FDG-PET/ MRI) within 42 days of study entry and additional imaging according to local standard of care

You may not qualify if:

  • Pregnant or lactating women
  • Evidence of significant medical condition or laboratory finding which, in the opinion of the Investigator, makes it undesirable for the patient to participate in the trial
  • Participants with severe claustrophobia or who are unable to lie flat or fit into the scanner (≥350 lbs (160 Kg))
  • Prior use within 14 days of enrolment or concurrent therapy with any other investigational agent
  • Patients classified as radiation workers
  • Patient has previously received treatment with CDK 4/6 inhibitors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust/ Imperial College London

London, W12 0NN, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tissue

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Laura Kenny

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 19, 2020

Study Start

February 24, 2022

Primary Completion

November 3, 2023

Study Completion

November 3, 2023

Last Updated

August 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)