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Lymphatic Mapping Of Oropharyngeal Cancer (LOOC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04498221
Recruitment Status : Not yet recruiting
First Posted : August 4, 2020
Last Update Posted : February 17, 2022
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University College, London

Brief 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.

Condition or disease Intervention/treatment Phase
Oropharyngeal Cancer Procedure: Imaging procedure Procedure: Surgical procedure Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective, Multi-Centre, Phase II Validation Study for a Lymphatic Imaging Protocol in Establishing Drainage Patterns in Patients With Oropharyngeal Cancer
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : January 2027
Estimated Study Completion Date : January 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Imaging Phase
During routine examination under anaesthetic 4 x peritumoural injection of Lymphoseek (lymphatic mapping tracer) followed by freehand SPECT scan
Procedure: Imaging procedure
During routine examination under anaesthetic 4 x peritumoural injection of Lymphoseek (lymphatic mapping tracer) followed by freehand SPECT scan

Experimental: Surgical Phase
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.
Procedure: 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.




Primary Outcome Measures :
  1. Rate of contralateral drainage [ Time Frame: 24 hours post injection ]
    Rate of contralateral drainage

  2. 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

  3. 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

  4. 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.

  5. Acceptability to patients assessed by questionnaire. [ Time Frame: 24 hours post injection ]
    Acceptability to patients assessed by questionnaire.

  6. Occult metastastatic rate of contralateral nodes (positive sentinel node biopsy). [ Time Frame: 24 hours post injection ]
    Occult metastastatic rate of contralateral nodes (positive sentinel node biopsy).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04498221


Contacts
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Contact: Charlie Mizon 02076799280 situ.looc@ucl.ac.uk
Contact: Norman R Williams norman.williams@ucl.ac.uk

Locations
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United Kingdom
University College Hospital
London, United Kingdom
Contact: Charlie Mizon       situ.looc@ucl.ac.uk   
Sponsors and Collaborators
University College, London
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Clare Schilling University College, London
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT04498221    
Other Study ID Numbers: 127659
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: February 17, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No identifiable data will be shared with anyone outside the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Oropharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases