Lymphatic Mapping Of Oropharyngeal Cancer

Oropharyngeal Cancer Clinical Trial

— LOOC  

Official title:

Prospective, Multi-Centre, Phase II Validation Study for a Lymphatic Imaging Protocol in Establishing Drainage Patterns in Patients With Oropharyngeal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04498221
• Other study ID #: 127659
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2022
• Est. completion date: January 2027

Study information

• Verified date: October 2023
• Source: University College, London
• Contact: Trial Manager
• Phone: 02076799274
• Email: ncita.looc[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multi-centre validation study to evaluate whether a new imaging and surgical protocol would work as well as the current god standard in identifying sentinel nodes in patients with oropharyngeal cancer.

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 HPV virus 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 radioactive substance called Lymphoseek will be injected into the tumour. Lymphoseek moves quickly into the lymph nodes and can then be detected using a handheld gamma camera. The first nodes that Lymphoseek moves into are the "sentinel" nodes. Patients already undergo an examination under anaesthetic (EUA); the patients participating in the study will have the Lymphoseek 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 Lymphoseek under local anaesthetic in an outpatient clinic. In the study this will take place several days after the initial injection with Lymphoseek. If this procedure is found to be acceptable to patients, it would mean that patients could have the Lymphoseek 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Oropharyngeal Cancer
• Oropharyngeal Neoplasms

Intervention

Procedure:
• Imaging procedure
During routine examination under anaesthetic 4 x peritumoural injection of Lymphoseek (lymphatic mapping tracer) followed by freehand SPECT scan
• Surgical procedure
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.

Locations

Country	Name	City	State
United Kingdom	University College Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of contralateral drainage	Rate of contralateral drainage	24 hours post injection
Primary	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	24 hours post injection
Primary	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	24 hours post injection
Primary	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.	24 hours post injection
Primary	Acceptability to patients assessed by questionnaire.	Acceptability to patients assessed by questionnaire.	24 hours post injection
Primary	Occult metastastatic rate of contralateral nodes (positive sentinel node biopsy).	Occult metastastatic rate of contralateral nodes (positive sentinel node biopsy).	24 hours post injection