Head and Neck Cancer Clinical Trial
— FLEX-NODEOfficial title:
Sentinel Node Localization in Larynx and Pharynx Cancers After Flexible Endoscopy-guided Tracer Injection: a Feasibility Study.
Verified date | April 2022 |
Source | Radboud University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study explores the feasibility of sentinel lymph node identification in pharynx and larynx cancers using flexible endoscopy-guided tracer injection.
Status | Completed |
Enrollment | 16 |
Est. completion date | January 11, 2022 |
Est. primary completion date | January 11, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male or female aged >18 years. - Mucosal tumor of the oropharynx, hypopharynx or larynx. - Patients planned to undergo biopsy via flexible endoscopy. - Patients planned to undergo curative radiotherapy with or without concurrent chemotherapy. - Patient provided written informed consent. Exclusion Criteria: - Patients who underwent previous surgery or radiotherapy to the neck. - Patients with airway obstruction causing stridor. - Prior allergic reaction to Tc-99m-nanocolloïd. - Pregnancy. - Unable to provide informed consent. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboudumc | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Generation of SPECT-images of sufficient quality for localization of the sentinel node(s) after peritumoral Tc-99m-nanocolloid injection guided by flexible endoscopy. | All SPECT images will be assessed qualitatively by concerted consensus between a nuclear medicine physician, head and neck surgeons and a radiation oncologist. Aspects that will be evaluated include:
Is there sufficient uptake of tracer for identification and localization of lymph nodes? Does tracer uptake in primary tumor interfere with lymph node identification? Is sentinel lymph node localization consistent with what can be expected with normal, undisturbed lymph node drainage and what is known from the literature? |
The data of each patient will be assessed within 6 months. | |
Secondary | Feasibility of administering at least 2 peritumoral Tc-99m-nanocolloid injections during one procedure of flexible endoscopy. | The procedure will be documented on video and will be reviewed by the investigational team for accuracy of tracer injections and learning purposes. | The data of each patient will be assesses within 6 months. | |
Secondary | Comparison between sentinel nodes identified by SPECT and sentinel nodes identified by routine CT or MRI. | All SPECT and CT or MR images will be assessed qualitatively by concerted consensus between a nuclear medicine physician, head and neck surgeons and a radiation oncologist. For this outcome measure the following aspect is visually evaluated: can the lymph nodes identified as sentinel nodes by SPECT also be localized on routine diagnostic imaging (CT, MRI, ultrasound)? | The data of each patient will be assesses within 6 months. |
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