Validation Study of a New Imaging and Surgical Protocol for Detecting Lymph Node Spread in Oropharyngeal Cancer Patients
Led by University College, London · Updated on 2024-09-19
150
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Oropharyngeal cancer often spreads to lymph nodes in the neck, and treatment involves addressing both the original tumor and any spread to these nodes. Deciding whether to treat both sides of the neck can be challenging because the cancer may spread to the opposite side. This study aims to evaluate if a new imaging and surgical approach using sentinel node biopsy can more accurately determine if the cancer has spread to the other side of the neck, potentially improving treatment decisions.
The study involves two main stages imaging and surgery. In the imaging stage, a small amount of a radioactive tracer either Human albumin colloidal particles or Lymphoseek is injected near the tumor during an examination under anesthesia. A handheld gamma camera and a CT scan are used to detect the first lymph nodes sentinel nodes that the tracer reaches. In the surgery stage, patients with sentinel nodes detected on the opposite side of the neck may have those nodes removed during the examination under anesthesia to check for cancer spread. Some patients may also receive a second tracer injection under local anesthesia in an outpatient setting to test if it helps identify sentinel nodes before anesthesia.
Participants will undergo tracer injections, imaging scans, and possibly node removal during examination under anesthesia. Researchers will measure how accurately the new imaging methods identify sentinel nodes on the opposite side of the neck, the number and location of these nodes, and patient acceptance using questionnaires. The study will monitor for hidden cancer spread in sentinel nodes and aims to provide better information about cancer spread without extra anesthesia. Participation may last throughout the imaging and surgical assessments as scheduled by the study.
CONDITIONS
Brief Title
Lymphatic Mapping Of Oropharyngeal Cancer
Research Team
T
Trial Manager
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National Institute for Health Research, United Kingdom
Collaborating Sponsor
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Adults aged 18 or over
New diagnosis of oropharyngeal cancer at any anatomical subsite and HPV status
Unilateral metastatic lymph nodes with clinical staging N1-N2b for P16 negative or N1 for P16 positive patients
You will not qualify if you...
Suspicious bilateral lymph nodes on imaging
Previous radiotherapy or surgery to the neck
Second primary oropharyngeal tumors
Distant metastasis such as lung or bone
Pregnancy or breastfeeding
Inability to give informed consent
Allergy to lymphatic tracers
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Imaging Phase
Duration - Approximately 1 day
Participants receive a low dose radioactive tracer injection around the tumour during a routine examination under anaesthetic, followed by a freehand SPECT scan to identify sentinel lymph nodes.
1 visit (under anaesthetic) plus 1 follow-up CT scan the next day
Surgical Phase
Duration - 1 day
Participants identified with sentinel nodes on the other side of the neck undergo removal of these nodes during a routine examination under anaesthetic for further examination.
1 surgical visit (under anaesthetic)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Published Research Related To This Trial
Lymphatic mapping Of Oropharyngeal Cancer (LOOC): protocol for a phase II surgical imaging trial to evaluate contralateral drainage and occult metastasis in oropharyngeal cancer.