NCT03198442

Brief Summary

Breast PET may be able to help in the diagnostic pathway in patients to determine which ones need to go on to have a second look ultrasound +/- biopsy and those who need to be sent for MRI guided biopsy. This may reduce the need to create more anxiety and uncertainty in this group of patients, already extremely stressed by the recent diagnosis of breast cancer.This study involves a single trial visit the Royal Free Hospital for imaging. Participants will need to lie flat for up to 30 minutes on the PET-CT camera and up to 30 minutes on the MAMMI. They will be advised not to take part in this study if they are unable to lie flat on their back and their front for this length of time or if they are claustrophobic. They will be offered the opportunity to see the PET-CT scanner and the MAMMI before deciding to consent to the trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

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

Study Start

First participant enrolled

October 5, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2019

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

2.4 years

First QC Date

March 16, 2017

Last Update Submit

March 23, 2020

Conditions

Breast Neoplasm Female

Outcome Measures

Primary Outcomes (1)

  • Recruitment rate

    To assess the feasibility and acceptability to patients of F-18 FDG breast PET scans, by determining how many patients can be recruited over two years.

    Two years.

Secondary Outcomes (4)

  • Comparison with standard-of-care assessments

    Two weeks

  • Eligibility barriers to recruitment

    Two years.

  • Comparison with whole-body PET

    Two weeks

  • Sample size calculation

    Two years.

Study Arms (1)

Breast PET

EXPERIMENTAL

PET imaging of breast with patient in prone position.

Procedure: F-18 FDG breast PET scan

Interventions

F-18 FDG breast PET scanPROCEDURE
Also known as: MAMMI
Breast PET

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale only.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Age over 18 (no upper limit).
  • Not pregnant.
  • Not breastfeeding.
  • Indeterminate breast lesion on MRI requiring a second-look ultrasound.
  • Ability to lie still for up to 30 minutes prone and supine.
  • Females of childbearing potential have a negative pregnancy test within 7 days prior to being registered. Participants are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
  • Willing and able to provide written informed consent.

You may not qualify if:

  • Females who are pregnant, planning pregnancy or breastfeeding
  • Concurrent and/or recent involvement in other research that is likely to interfere with the intervention within 3 months prior to study enrolment
  • Inability to lie flat or undergo the tests.
  • Any co-morbidities or conditions which in the opinion of the clinical team means that the patient should be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Study Officials

  • Thomas Wagner

    Royal Free Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Small cohort.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2017

First Posted

June 26, 2017

Study Start

October 5, 2016

Primary Completion

March 4, 2019

Study Completion

March 4, 2019

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

All requests for data sharing will adhere to the UCL Surgical \& Interventional Trials Unit (SITU) data sharing agreement policy. UCL Medical School is supportive of data sharing and will endeavour to assist in requests for data sharing. These data will be held on secure servers and will not be released to any third parties until all the main outputs from the studies have been published. All requests for access to the data will be formally requested through the use of a SITU data request form which will state the purpose, analysis and publication plans together with the named collaborators. All requests are dealt with on a case by case basis by SITU and the Chief Investigator. All requests will be logged and those successful will have a data transfer agreement which will specify appropriate acknowledgement of the Chief Investigator and study group, the sponsor, and funders.

Locations

GB(1)