Gamma probe detection in patients undergoing a PET scan
| ISRCTN | ISRCTN29552671 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29552671 |
| Secondary identifying numbers | Version 1.1 16/12/2013 |
- Submission date
- 07/02/2014
- Registration date
- 24/04/2014
- Last edited
- 07/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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?
St Thomas Hospital (UK)
When is the study starting and how long is it expected to run for?
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
Contact information
Scientific
3rd floor Bermondsey Wing
Guy's Hospital
Great Maze Pond
London
Se1 9RT
United Kingdom
| maarten.grootendorst@kcl.ac.uk |
Study information
| Study design | Observational non-randomised study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Other |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Gamma-probe cross talk from 18F-FDG in technetium-99m energy window |
| Study objectives | 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(s) | South East Scotland Research Ethics Committee 01, 31/01/2014, ref: 14/SS/0013 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | The highest and lowest measurement detected by the gamma probe in patients injected with 18F-FDG |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 15/02/2014 |
| Completion date | 15/05/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 20 |
| Total final enrolment | 20 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 15/02/2014 |
| Date of final enrolment | 15/05/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Se1 9RT
United Kingdom
Sponsor information
Hospital/treatment centre
Room 1.8 Hodgkin Building
Guy's Campus
London
SE1 1UL
England
United Kingdom
"ROR" |
https://ror.org/0220mzb33 |
|---|
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Collegium Regale Londiniense, King's, KCL
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2017 | 07/08/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
07/08/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
29/03/2017: No publications found, verifying study status with principal investigator.
