Condition category
Cancer
Date applied
07/02/2014
Date assigned
24/04/2014
Last edited
10/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Sentinel lymph node biopsy (SLNB) is the standard method used to assess the lymph nodes in the armpit in breast cancer patients when these are not palpable (felt by touch) or seen on ultrasound imaging. The gold standard for SLNB is the combined technique, using both radioactive tracer (a radioactive substance used in medical imaging) and blue dye. Technetium 99m (99mTc) is the tracer used in SLNB and is detected by a handheld device called a gamma probe. The readings from the gamma probe and/or the discolouration from the blue dye are used to find the SLNs. About 25-30% of patients undergoing SLNB will have cancer cells in the SLNs. In these patients all the lymph nodes in the armpit need to be removed – a procedure known as axillary node clearance (ANC). At the moment the procedure is performed during a second operation, because there are no accurate techniques that can assess the SLN during the initial surgery. Cerenkov Luminescence Imaging (CLI) is a recently-discovered technique based on the observation that radiotracers also generate visible light. CLI allows widely available Positron Emission Tomography (PET) radiotracers, including 18F-fluorodeoxyglucose (18F-FDG), to be imaged. The uptake of 18F-FDG is generally greater in tumour tissue than in healthy tissue. This allows the cancerous tissue and non-cancerous tissue to be identified. 18F-FDG can also be detected by the gamma probe commonly used in SLNB. The gamma-probe signal from 18F-FDG may cause interference with the gamma-probe signal from 99mTc (called cross talk). This might interfere with SLNB procedure. This study has been designed to look at the amount of cross talk between the gamma-probe signal from 18F-FDG and the gamma-probe signal from 99mTc.

Who can participate?
Female patients aged 18 or over who are about to have a routine PET-scanning procedure will be invited to take part.

What does the study involve?
Participants will receive an injection of the radioisotope 18F-FDG for the PET scan. After they have been given the injection, a gamma probe will be placed in their right and then left armpit. The highest and lowest signal will be measured.

What are the possible benefits and risks of participating?
There are no direct benefits to the patient; however, participation in the study may benefit future patients undergoing surgery for breast cancer if the technique works. There are no risks or side effects associated with this research study. The patient will not receive any drugs or undergo any invasive procedures as part of the study and the routine care will not be affected. This study is purely observational.

Where is the study run from?
The study will be conducted at the clinical PET centre at St Thomas’ Hospital (UK).

When is the study starting and how long is it expected to run for?
The study ran from February to May 2014.

Who is funding the study?
King's College London (UK).

Who is the main contact?
Maarten Grootendorst
maarten.grootendorst@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Maarten Grootendorst

ORCID ID

Contact details

3rd floor Bermondsey Wing
Guy's Hospital
Great Maze Pond
London
Se1 9RT
United Kingdom
maarten.grootendorst@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

version 1.1 16/12/2013

Study information

Scientific title

Gamma-probe cross talk from 18F-FDG in technetium-99m energy window

Acronym

Study hypothesis

The cross talk information will aid in establishing the required activities (MBq) of technetium-99 and 18F-FDG to enable successful sentinel lymph node (SLN) detection.

Ethics approval

South East Scotland Research Ethics Committee 01, 31/01/2014, Ref.: 14/SS/0013

Study design

Observational non-randomised study

Primary study design

Observational

Secondary study design

Other

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Cancer

Intervention

This study has been designed to look at the amount of cross talk between the gamma-probe signal from 18F-FDG and the gamma-probe signal from 99mTc. Patients that are about to have a routine PET-scanning procedure will be invited to take part. They will receive an injection of the radioisotope 18F-FDG for the PET scan. After they have been given the injection, a gamma probe will be placed in their right and then left armpit. The highest and lowest signal will be measured. The study will be conducted at the clinical PET centre at St Thomas’ Hospital, and a maximum of 20 patients will take part in the study. There will be no further follow-up or patient contact once measurements have been obtained.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

What is the highest and lowest measurement detected by the gamma probe in patients injected with 18F-FDG?

Secondary outcome measures

No secondary outcome measures

Overall trial start date

15/02/2014

Overall trial end date

15/05/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female patients ≥ 18 years of age who are willing to participate in the study and who provide written informed consent
2. Patients receiving an intravenous 18F-FDG injection for a diagnostic PET-scan as part of routine care

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

20

Participant exclusion criteria

Patients with high 18F-FDG uptake in the thoracic or axillary region. The PET-report will be reviewed the day after the PET-scan to identify these patients. Hence, these patients will be excluded retrospectively.

Recruitment start date

15/02/2014

Recruitment end date

15/05/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

3rd floor Bermondsey Wing
London
Se1 9RT
United Kingdom

Sponsor information

Organisation

King's College London - Guy's and St.Thomas' Foundation Trust (UK)

Sponsor details

Room 1.8 Hodgkin Building
Guy's Campus
London
SE1 1UL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

King's College London (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes