Oropharyngeal CancerLOOCNCT04498221
Lymphatic Mapping Of Oropharyngeal Cancer
A study testing Imaging procedure and Surgical procedure in people with Oropharyngeal Cancer, run by University College, London at 2 sites in United Kingdom.
Trial summary
A multi-centre validation study to evaluate whether a new imaging and surgical protocol would work as well as the current gold standard in identifying sentinel nodes in patients with oropharyngeal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Cancer
- What is being tested?
- Imaging procedure and Surgical procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 7 Jul 2022to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 or over
- New diagnosis of OPC - all anatomical subsites and HPV status accepted
- Unilateral metastatic nodes equating to AJCC TNM8 clinical staging N1-N2b for P16 negative and N1 for P16 positive patients.
Who cannot join
- Suspicious bilateral nodes on imaging
- Previous radiotherapy or surgery to the neck
- Second primary oropharyngeal tumours
- Distant metastasis (e.g. lung, bone)
- Pregnancy and lactation
- Inability to give informed consent
- Allergy to lymphatic tracers
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
St George's University Hospitals NHS Foundation Trust
London, SW17 0QT
Enyi Ofo
- Recruiting
University College Hospital
London
Clare Schilling, ncita.looc@ucl.ac.uk
About this study
Official title: Prospective, Multi-Centre, Phase II Validation Study for a Lymphatic Imaging Protocol in Establishing Drainage Patterns in Patients With Oropharyngeal Cancer
A multi-centre validation study to evaluate whether a new imaging and surgical protocol would work as well as the current gold standard in identifying sentinel nodes in patients with oropharyngeal cancer.
Read the detailed description
Cancer at the back of the mouth and throat is usually discovered after it has spread to lymph glands in the neck. Treatment therefore involves dealing with both the original tumour (in the mouth/throat) and the spread cancer in the lymph glands. This type of cancer sometimes spreads to both sides of the neck, not just the side on which the original tumour was located. The decision as to whether to treat the other side of the neck as well depends on various factors including the aggressiveness of the tumour, whether the patient smokes and whether or not the Human Papilloma Virus (HPV) is present in the tumour. This is inevitably inexact, and assessing the likelihood of the cancer spreading to the other side of the neck always involves an element of estimation. Some patients end up being treated unnecessarily on both sides (often with severe and lasting effects on swallowing, meaning they have to use a feeding tube), while others receive treatment on one side only but the cancer comes back on the other side.
This study will provide more accurate information on which to base the decision as to whether to treat the other side of the neck. The study will use a procedure known as sentinel node biopsy (SNB) to establish (with a high degree of accuracy) whether or not the cancer has spread to the other side of the neck. The study will be in two stages. The first stage is the imaging stage. A very low does of a radioactive tracer substance will be injected into the tumour. The radioactive tracers used in this study are either Human albumin colloidal particles or Lymphoseek. Once injected, they move quickly into the lymph nodes and can then be detected using a handheld gamma camera. The first nodes that the radiotracer moves into are the "sentinel" nodes. Patients already undergo an examination under anaesthetic (EUA); the patients participating in the study will have the radiotracer injected additionally and the sentinel nodes detected during this EUA. The use of the handheld camera is relatively new; so, all of the patients in the study will also have a CT scan the next day to double check whether the handheld camera identified the sentinel nodes correctly. The second stage of the study, the surgery stage, will involve a new group of patients having the imaging procedure. Those who do have sentinel nodes in the other side of the neck will have them removed during the EUA. Those nodes will then be examined thoroughly for signs of cancer. A separate limb of stage one of the study will involve some patients whose main tumours are easily accessible also having their tumour injected with the radiotracer a second time under local anaesthetic in an outpatient clinic. In the study this will take place several days after the initial injection with the radiotracer. If this procedure is found to be acceptable to patients, it would mean that patients could have the radiotracer injected before the EUA, thereby allowing time for the sentinel nodes to be identified by CT scan so that they can be removed during the EUA. This will provide a way to ensure that, even if the handheld camera cannot be used, the sentinel nodes can still be removed while the patient is under anaesthetic for the EUA. If the study is successful, the patient will be able to have much more accurate information about whether their cancer has, or might, spread to the other side of the neck, without having to undergo an additional general anaesthetic.
- Conditions
- Oropharyngeal Cancer
- Being tested
- Imaging procedure, Surgical procedure
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging procedureProcedure or surgery
During routine examination under anaesthetic 4 x peritumoural injection of investigator's choice of 99mTc-human albumin colloidal particles or Lymphoseek (lymphatic mapping tracer) followed by freehand SPECT scan
Surgical procedureProcedure or surgery
Excision of contralateral nodes identified on imaging *(fhSPECT or SPECT/CT*) during routine examination under anaesthetic. Serial sectioning of excised (sentinel) nodes to identify micrometastasis.
| Study group | Role | What they receive |
|---|---|---|
| Imaging Phase | Experimental | During routine examination under anaesthetic 4 x peritumoural injection of investigator's choice of 99mTc-human albumin colloidal particles or Lymphoseek (lymphatic mapping tracer) followed by freehand SPECT scan Receives: Procedure: Imaging procedure |
| Surgical Phase | Experimental | Excision of contralateral nodes identified on imaging *(fhSPECT or SPECT/CT*) during routine examination under anaesthetic. Serial sectioning of excised (sentinel) nodes to identify micrometastasis. Receives: Procedure: Surgical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of contralateral drainage
Rate of contralateral drainage
Measured: 24 hours post injection
Accuracy of detection of contralateral nodes by lymphoscintigraphy using fhSPECT compared to SPECT/CT
Accuracy of detection of contralateral nodes by lymphoscintigraphy using fhSPECT compared to SPECT/CT
Measured: 24 hours post injection
Number of contralateral nodes on SPECT/CT
Number of contralateral nodes on SPECT/CT will be used as the denominator in calculating the sensitivity of fhSPECT in independently verified images
Measured: 24 hours post injection
Number and location of contralateral nodes seen with lymphoscintigraphy performed by i) single injection ii) four peritumoural injections (standard practice) as assessed by paired SPECT/CT scans.
Number and location of contralateral nodes seen with lymphoscintigraphy performed by i) single injection ii) four peritumoural injections (standard practice) as assessed by paired SPECT/CT scans.
Measured: 24 hours post injection
Acceptability to patients assessed by questionnaire.
Acceptability to patients assessed by questionnaire.
Measured: 24 hours post injection
Occult metastasis rate of contralateral nodes (positive sentinel node biopsy).
Occult metastasis rate of contralateral nodes (positive sentinel node biopsy).
Measured: 24 hours post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start7 Jul 2022
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oropharyngeal CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Clare Schilling, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498221
- Sponsor's protocol ID
- 127659
- Acronym
- LOOC
- Status last verified
- Sep 2024
- First submitted
- 4 Dec 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No identifiable data will be shared with anyone outside the study
Publications
Schilling C, Payne K, Wan S, Brew-Graves C, Ofo E, Ambler G, Weller A, Gnanasegaran G, Paleri V, Shaw R, Fleming J, Walker D, Bajwa M, McGurk M. Lymphatic mapping Of Oropharyngeal Cancer (LOOC): protocol for a phase II surgical imaging trial to evaluate contralateral drainage and occult metastasis in oropharyngeal cancer. BMJ Open. 2025 Jun 5;15(6):e101746. doi: 10.1136/bmjopen-2025-101746.
PubMed 40473291
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Centre, Phase II Validation Study for a Lymphatic Imaging Protocol in Establishing Drainage Patterns in Patients With Oropharyngeal Cancer
- ClinicalTrials.gov ID
- NCT04498221
- Acronym / sponsor ID
- LOOC / 127659
- Conditions
- Oropharyngeal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-centre validation study to evaluate whether a new imaging and surgical protocol would work as well as the current gold standard in identifying sentinel nodes in patients with oropharyngeal cancer.
Detailed description
Cancer at the back of the mouth and throat is usually discovered after it has spread to lymph glands in the neck. Treatment therefore involves dealing with both the original tumour (in the mouth/throat) and the spread cancer in the lymph glands. This type of cancer sometimes spreads to both sides of the neck, not just the side on which the original tumour was located. The decision as to whether to treat the other side of the neck as well depends on various factors including the aggressiveness of the tumour, whether the patient smokes and whether or not the Human Papilloma Virus (HPV) is present in the tumour. This is inevitably inexact, and assessing the likelihood of the cancer spreading to the other side of the neck always involves an element of estimation. Some patients end up being treated unnecessarily on both sides (often with severe and lasting effects on swallowing, meaning they have to use a feeding tube), while others receive treatment on one side only but the cancer comes back on the other side.
This study will provide more accurate information on which to base the decision as to whether to treat the other side of the neck. The study will use a procedure known as sentinel node biopsy (SNB) to establish (with a high degree of accuracy) whether or not the cancer has spread to the other side of the neck. The study will be in two stages. The first stage is the imaging stage. A very low does of a radioactive tracer substance will be injected into the tumour. The radioactive tracers used in this study are either Human albumin colloidal particles or Lymphoseek. Once injected, they move quickly into the lymph nodes and can then be detected using a handheld gamma camera. The first nodes that the radiotracer moves into are the "sentinel" nodes. Patients already undergo an examination under anaesthetic (EUA); the patients participating in the study will have the radiotracer injected additionally and the sentinel nodes detected during this EUA. The use of the handheld camera is relatively new; so, all of the patients in the study will also have a CT scan the next day to double check whether the handheld camera identified the sentinel nodes correctly. The second stage of the study, the surgery stage, will involve a new group of patients having the imaging procedure. Those who do have sentinel nodes in the other side of the neck will have them removed during the EUA. Those nodes will then be examined thoroughly for signs of cancer. A separate limb of stage one of the study will involve some patients whose main tumours are easily accessible also having their tumour injected with the radiotracer a second time under local anaesthetic in an outpatient clinic. In the study this will take place several days after the initial injection with the radiotracer. If this procedure is found to be acceptable to patients, it would mean that patients could have the radiotracer injected before the EUA, thereby allowing time for the sentinel nodes to be identified by CT scan so that they can be removed during the EUA. This will provide a way to ensure that, even if the handheld camera cannot be used, the sentinel nodes can still be removed while the patient is under anaesthetic for the EUA. If the study is successful, the patient will be able to have much more accurate information about whether their cancer has, or might, spread to the other side of the neck, without having to undergo an additional general anaesthetic.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imaging Phase | Experimental | Procedure: Imaging procedureDuring routine examination under anaesthetic 4 x peritumoural injection of investigator's choice of 99mTc-human albumin colloidal particles or Lymphoseek (lymphatic mapping tracer) followed by freehand SPECT scan |
| Surgical Phase | Experimental | Procedure: Surgical procedureExcision of contralateral nodes identified on imaging *(fhSPECT or SPECT/CT*) during routine examination under anaesthetic. Serial sectioning of excised (sentinel) nodes to identify micrometastasis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 or over
- New diagnosis of OPC - all anatomical subsites and HPV status accepted
- Unilateral metastatic nodes equating to AJCC TNM8 clinical staging N1-N2b for P16 negative and N1 for P16 positive patients.
Key exclusion criteria (7 listed)
- Suspicious bilateral nodes on imaging
- Previous radiotherapy or surgery to the neck
- Second primary oropharyngeal tumours
- Distant metastasis (e.g. lung, bone)
- Pregnancy and lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging procedureDuring routine examination under anaesthetic 4 x peritumoural injection of investigator's choice of 99mTc-human albumin colloidal particles or Lymphoseek (lymphatic mapping tracer) followed by freehand SPECT scan | Procedure or surgery | Imaging Phase |
| Surgical procedureExcision of contralateral nodes identified on imaging *(fhSPECT or SPECT/CT*) during routine examination under anaesthetic. Serial sectioning of excised (sentinel) nodes to identify micrometastasis. | Procedure or surgery | Surgical Phase |
Primary outcome
Rate of contralateral drainage
Time frame: 24 hours post injection
Rate of contralateral drainage
Accuracy of detection of contralateral nodes by lymphoscintigraphy using fhSPECT compared to SPECT/CT
Time frame: 24 hours post injection
Accuracy of detection of contralateral nodes by lymphoscintigraphy using fhSPECT compared to SPECT/CT
Number of contralateral nodes on SPECT/CT
Time frame: 24 hours post injection
Number of contralateral nodes on SPECT/CT will be used as the denominator in calculating the sensitivity of fhSPECT in independently verified images
Number and location of contralateral nodes seen with lymphoscintigraphy performed by i) single injection ii) four peritumoural injections (standard practice) as assessed by paired SPECT/CT scans.
Time frame: 24 hours post injection
Number and location of contralateral nodes seen with lymphoscintigraphy performed by i) single injection ii) four peritumoural injections (standard practice) as assessed by paired SPECT/CT scans.
Acceptability to patients assessed by questionnaire.
Time frame: 24 hours post injection
Acceptability to patients assessed by questionnaire.
Occult metastasis rate of contralateral nodes (positive sentinel node biopsy).
Time frame: 24 hours post injection
Occult metastasis rate of contralateral nodes (positive sentinel node biopsy).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 40473291Schilling C, Payne K, Wan S, Brew-Graves C, Ofo E, Ambler G, Weller A, Gnanasegaran G, Paleri V, Shaw R, Fleming J, Walker D, Bajwa M, McGurk M. Lymphatic mapping Of Oropharyngeal Cancer (LOOC): protocol for a phase II surgical imaging trial to evaluate contralateral drainage and occult metastasis in oropharyngeal cancer. BMJ Open. 2025 Jun 5;15(6):e101746. doi: 10.1136/bmjopen-2025-101746.
- Individual participant dataSharing planned: No. No identifiable data will be shared with anyone outside the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clare Schilling principal investigator
University College, London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaging procedure and Surgical procedure in people with Oropharyngeal Cancer, run by University College, London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Manager (02076799274, ncita.looc@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of contralateral drainage (time frame: 24 hours post injection). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04498221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.