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Predictive Value of PET CT in the Histologic Lymph Node Status of Patients With Squamous Cell Carcinoma of the Oral N0 Clinical and Radiological Cavity. (ORNICA)
Squamous cell carcinoma of the VADS represents the majority of cancers in ENT. Metastatic lymph node involvement is an important prognostic factor. In N0 patients clinically and scanographically, the prevalence of cervical lymph node metastasis remains important. Only the anatomopathological analysis of cervical lymph node dissection confirms the presence of a micro-metastasis. However, new criteria of interpretation in nuclear medicine seem promising in the detection of lymph node lesions not detectable in traditional imaging.
The main objective of this study is to study the positive predictive value (PPV) of CT scans in the anatomo-pathological analysis of N0 clinical and radiological or N + unilateral neck ganglia in patients with squamous cell carcinoma of the oral cavity.
| Condition or disease | Intervention/treatment |
|---|---|
| Squamous Cell Carcinoma of the Oral Clinically Node-Negative and Radiology | Diagnostic Test: PET-CT |
The main objective is to study the positive predictive value of PET-CT in the identification of infra-clinical lymph node lesions for cancers of the oral cavity classified N0 or N + unilateral
Patients are admitted to ORL or maxillofacial consultation with initial clinical examination according to current recommendations (tumor evaluation, cervical palpation, locoregional examination).
A dated and signed diagram of the lesion and ganglionic areas will be made during this consultation.
A biopsy for histopathological examination of the lesion will be necessary to confirm the diagnosis of squamous cell carcinoma with P16 analysis. It will be performed during the consultation under local anesthesia if the lesion is accessible or under general anesthesia during panendoscopy.
All patients will benefit from an assessment of locoregional extension by CT cervicofacial and thoracic injected (in order to look for possible pulmonary metastases or suspicious mediastinal lymphadenopathies) as requested in the oncological recommendations and PET-CT. As part of the extension assessment, a panendoscopy or bronchial fibroscopy and gastro-oesophageal failure will be performed if risk factors ethanolotagagic are present.
If the lesion is not accessible for a biopsy during the inclusion visit, the patient is summoned for a panendoscopy. It is an examination under general anesthesia to make a biopsy of the primary tumor and to search for the absence of synchronous localization. In current practice, this examination requires overnight hospitalization.
The patient will be reviewed by the ORL or maxillofacial surgeon in consultation after receiving the anatomopathological findings of the lesion and the entire extension assessment (CT cervico-thoracic injected and PET-CT).
On CT PET, an analysis with additional interpretation criteria will be performed (SUVmax, SUV peak, MTG) on the primary tumor and on the invaded lymph nodes. A ganglion is considered invaded when its SUV is suppressed at 30% of the SUV of the original lesion.
The patient's file will have been previously presented in a Multidisciplinary Concertation Meeting, whose treatment will consist of a surgical excision of the primary lesion and a lymph node dissection.
The patient will be seen again in consultation at 10 days of his intervention as part of the follow-up postoperative in order to be able to receive all the anatomopathologic results of the operative specimen and ganglion dissection. The patient's record will have been represented in CPR in order to decide whether or not to have an adjuvant treatment based on the anatomopathological characters (capsular rupture, number of ganglions invaded, peri-nervous sheath).
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 40 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 50 Days |
| Official Title: | Predictive Value of PET CT in the Histologic Lymph Node Status of Patients With Squamous Cell Carcinoma of the Oral N0 Clinical and Radiological Cavity. |
| Actual Study Start Date : | August 21, 2019 |
| Estimated Primary Completion Date : | August 20, 2021 |
| Estimated Study Completion Date : | August 20, 2021 |
- metastatic lymph node involvement [ Time Frame: 30 days ]The outcome is analyzing histologic metastatic lymph node. The outcome data table will include the presence of histologic metastatic lymph node, localization of the lymph invaded, presence of capsular rupture, and preoperative TEP CT data.
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 9, 2019 | ||||
| First Posted Date | May 13, 2019 | ||||
| Last Update Posted Date | September 22, 2020 | ||||
| Actual Study Start Date | August 21, 2019 | ||||
| Estimated Primary Completion Date | August 20, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
metastatic lymph node involvement [ Time Frame: 30 days ] The outcome is analyzing histologic metastatic lymph node. The outcome data table will include the presence of histologic metastatic lymph node, localization of the lymph invaded, presence of capsular rupture, and preoperative TEP CT data.
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| Original Primary Outcome Measures |
metastatic lymph node involvement [ Time Frame: 30 days ] | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Predictive Value of PET CT in the Histologic Lymph Node Status of Patients With Squamous Cell Carcinoma of the Oral N0 Clinical and Radiological Cavity. | ||||
| Official Title | Predictive Value of PET CT in the Histologic Lymph Node Status of Patients With Squamous Cell Carcinoma of the Oral N0 Clinical and Radiological Cavity. | ||||
| Brief Summary |
Squamous cell carcinoma of the VADS represents the majority of cancers in ENT. Metastatic lymph node involvement is an important prognostic factor. In N0 patients clinically and scanographically, the prevalence of cervical lymph node metastasis remains important. Only the anatomopathological analysis of cervical lymph node dissection confirms the presence of a micro-metastasis. However, new criteria of interpretation in nuclear medicine seem promising in the detection of lymph node lesions not detectable in traditional imaging. The main objective of this study is to study the positive predictive value (PPV) of CT scans in the anatomo-pathological analysis of N0 clinical and radiological or N + unilateral neck ganglia in patients with squamous cell carcinoma of the oral cavity. |
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| Detailed Description |
The main objective is to study the positive predictive value of PET-CT in the identification of infra-clinical lymph node lesions for cancers of the oral cavity classified N0 or N + unilateral Patients are admitted to ORL or maxillofacial consultation with initial clinical examination according to current recommendations (tumor evaluation, cervical palpation, locoregional examination). A dated and signed diagram of the lesion and ganglionic areas will be made during this consultation. A biopsy for histopathological examination of the lesion will be necessary to confirm the diagnosis of squamous cell carcinoma with P16 analysis. It will be performed during the consultation under local anesthesia if the lesion is accessible or under general anesthesia during panendoscopy. All patients will benefit from an assessment of locoregional extension by CT cervicofacial and thoracic injected (in order to look for possible pulmonary metastases or suspicious mediastinal lymphadenopathies) as requested in the oncological recommendations and PET-CT. As part of the extension assessment, a panendoscopy or bronchial fibroscopy and gastro-oesophageal failure will be performed if risk factors ethanolotagagic are present. If the lesion is not accessible for a biopsy during the inclusion visit, the patient is summoned for a panendoscopy. It is an examination under general anesthesia to make a biopsy of the primary tumor and to search for the absence of synchronous localization. In current practice, this examination requires overnight hospitalization. The patient will be reviewed by the ORL or maxillofacial surgeon in consultation after receiving the anatomopathological findings of the lesion and the entire extension assessment (CT cervico-thoracic injected and PET-CT). On CT PET, an analysis with additional interpretation criteria will be performed (SUVmax, SUV peak, MTG) on the primary tumor and on the invaded lymph nodes. A ganglion is considered invaded when its SUV is suppressed at 30% of the SUV of the original lesion. The patient's file will have been previously presented in a Multidisciplinary Concertation Meeting, whose treatment will consist of a surgical excision of the primary lesion and a lymph node dissection. The patient will be seen again in consultation at 10 days of his intervention as part of the follow-up postoperative in order to be able to receive all the anatomopathologic results of the operative specimen and ganglion dissection. The patient's record will have been represented in CPR in order to decide whether or not to have an adjuvant treatment based on the anatomopathological characters (capsular rupture, number of ganglions invaded, peri-nervous sheath). |
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| Study Type | Observational [Patient Registry] | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 50 Days | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population |
The population selected is that of any patient with squamous cell carcinoma of the oral cavity classified N0 clinical and radiological or unilateral N +, M0, not challenged for tumor resection surgery and bilateral cervical dissection. They will benefit in their assessment of extension of a PET-CT. Patients will be selected during an ENT or maxillofacial consultation. They will receive clear and appropriate information from the study. They will decide whether to participate in the study. |
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| Condition |
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| Intervention | Diagnostic Test: PET-CT
A PET-CT scan will be performed systematically for all patients included with the SUVmax, SUV peak, MTV of the lesion, and up to 3 suspicious ganglia during the visual analysis.
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
40 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | August 20, 2021 | ||||
| Estimated Primary Completion Date | August 20, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | |||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03947892 | ||||
| Other Study ID Numbers | 38RC19.064 2019-A00883-54 ( Other Identifier: ID RCB ) |
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| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | University Hospital, Grenoble | ||||
| Study Sponsor | University Hospital, Grenoble | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | University Hospital, Grenoble | ||||
| Verification Date | September 2020 | ||||
