D4 Choline Breast PET/CT

January 9, 2023 updated by: Imperial College London

Investigation of Changes in Tumour Choline Metabolism in Estrogen-receptor Positive / HER2 Negative Breast Cancer Patients Treated With CDK4/6 Inhibitors and Endocrine Therapy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A target of 16 evaluable participants will be recruited to this study. Participants will have[18F]D4-FCH PET/CT imaging on each of 2 visits Scan 1: Baseline scan to be conducted prior to initiating standard of care CDK4/6 inhibitor-based therapy drug therapy.

Scan2: Early post-treatment scan to be conducted at 4-6 weeks after initiating therapy.

Each participant will provide written consent to take part in the study before they undergo screening assessments to confirm eligibility. On the day of imaging the participants will have a blood sample taken for circulating tumour DNA prior to the scan.

A single dose of [18F]D4-FCH IV will be administered to the participant followed by dynamic/ whole body imaging.

Optional tumour biopsies at baseline and after 4-6 weeks of CDK4/6 inhibitor treatment will be obtained, or if there is a suitable archival pre-treatment biopsy that has been taken within 18 months, this can be retrieved for baseline analysis.

Clinical data for progression/ survival followed up for up to 24 months.

Study Type

Observational

Enrollment (Anticipated)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Female patients with a histological diagnosis of locally advanced or metastatic estrogen-receptor positive, HER2 negative breast cancer
  2. Written informed consent prior to admission in the study.
  3. Target lesion diameter of ≥15mm that has not been previously irradiated and is located outside the liver
  4. Female patients aged ≥ 18 years of age
  5. For all patients: histologically confirmed locally advanced/ metastatic breast cancer with a previous biopsy confirming hormone receptor and HER2 status
  6. ECOG performance status 0-2
  7. 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
  8. Life expectancy > 3months

  9. Adequate organ function as judged by investigator to include:

    • Hb≥ 10g/L
    • Creatinine clearance ≥45ml/min
  10. 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

Exclusion Criteria:

  1. Pregnant or lactating women
  2. 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
  3. Participants with severe claustrophobia or who are unable to lie flat or fit into the scanner (≥350 lbs (160 Kg))
  4. Prior use within 14 days of enrolment or concurrent therapy with any other investigational agent
  5. Patients classified as radiation workers
  6. Patient has previously received treatment with CDK 4/6 inhibitors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Through scan completion 4-6 weeks
PET/CT
Through scan completion 4-6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Through study completion, an average 2.5 years
PET/CT
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
Time Frame: Through study completion, an average 2.5 years
PET/CT
Through study completion, an average 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Medical Research Council
ECMC

Investigators

  • Principal Investigator: Laura Kenny, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2022

Primary Completion (Anticipated)

November 3, 2023

Study Completion (Anticipated)

November 3, 2024

Study Registration Dates

First Submitted

February 17, 2020

First Submitted That Met QC Criteria

February 17, 2020

First Posted (Actual)

February 19, 2020

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18HH4880
  • 249165 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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