D4 Choline Breast PET/CT

• Sponsor: Imperial College London (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04276272
• Collaborator: Medical Research Council (Other), ECMC (Other)
• Enrollment: 16
• Location: 1
• Anticipated Duration (Months): 51.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HER2-negative Breast Cancer; ER Positive Breast Cancer; Metastatic Breast Cancer	Other: Imaging scan

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 Design

• Study Type: Observational
• Anticipated Enrollment: 16 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Investigation of Changes in Tumour Choline Metabolism in Estrogen-receptor Positive / HER2 Negative Breast Cancer Patients Treated With CDK4/6 Inhibitors and Endocrine Therapy
• Anticipated Study Start Date: Aug 1, 2020
• Anticipated Primary Completion Date: Nov 3, 2022
• Anticipated Study Completion Date: Nov 3, 2024

Outcome Measures

Primary Outcome Measures

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 [Through scan completion 4-6 weeks]

   PET/CT

Secondary Outcome Measures

1. 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]

   PET/CT

2. 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]

   PET/CT

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female

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

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Imperial College Healthcare NHS Trust/ Imperial College london	London		United Kingdom	W12 0NN

Sponsors and Collaborators

• Imperial College London
• Medical Research Council
• ECMC

Investigators

• Principal Investigator: Laura Kenny, Imperial College London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT04276272
• Other Study ID Numbers: 18HH4880; 249165
• First Posted: Feb 19, 2020
• Last Update Posted: May 27, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Imperial College London: PET/CT
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of May 27, 2020