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Status unknownNCT03727594Updated Nov 1, 2018

Radioguided Selective Neck Dissection for Staging and Treatment of Oral Cavity and Oropharyngeal Squamous Cell Carcinoma

An observational study in Oral Cavity Squamous Cell Carcinoma and Oropharyngeal Squamous Cell Carcinoma, sponsored by University Hospital of Ferrara. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2018-11-01.

Sponsored by University Hospital of Ferrara · Observational

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 95 Years
Sex
All
01

Study summary

The purpose of the study is to assess the role of lymphoscintigraphy as a simple and widely accessible method with a favorable cost/benefit ratio in improving oral cavity and oropharyngeal squamous cell carcinoma staging and surgical appropriateness and implementing a tailored surgical approach to cervical lymph node dissection.

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Conditions studied

  • Oral Cavity Squamous Cell Carcinoma
  • Oropharyngeal Squamous Cell Carcinoma
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 50 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

University Hospital of Ferrara is the lead sponsor of 110 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients affected by oral cavity or oropharyngeal squamous cell carcinoma admitted to our clinic.

Inclusion criteria

  • accepted informed consent
  • preoperative histological diagnosis of oral cavity or oropharyngeal squamous cell carcinoma
  • patients fit to surgery of the primitive tumor and neck dissection (according to the general health condition and the clinical tumor stage)

Exclusion criteria

Exclusion Criteria:

  • rejected informed consent
  • patients not fit to surgery (according to the general health condition and the clinical tumor stage)
  • pregnant women
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Number of patients with atypical lymphatic drainage of oral cavity and oropharyngeal squamous cell carcinoma identified through lymphoscintigraphy

    Time frame: 5 years

  2. Number of metastasis or micrometastasis in the "sentinel" lymphnodes identified through immunofluorescence analysis of pancytokeratins

    Time frame: 5 years

  3. Overall survival

    Prognosis of radioguided neck dissection surgery compared to the standardized neck dissection traditionally performed in consideration of the site and the characteristics of the tumor and the clinical status of lymphnodes.

    Time frame: 5 years

  4. Disease-free survival

    Prognosis of radioguided neck dissection surgery compared to the standardized neck dissection traditionally performed in consideration of the site and the characteristics of the tumor and the clinical status of lymphnodes.

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • University Hospital of Ferrara
    Ferrara, 44124, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03727594
Lead sponsor
University Hospital of Ferrara
Responsible party
Nicola Malagutti (Principal Investigator, University Hospital of Ferrara) — Principal investigator
First posted
Nov 1, 2018
Start date
Jan 2016
Primary completion
Jan 2020 (estimated)
Completion
Jan 2021 (estimated)
Last update
Nov 1, 2018

Study contacts

Nicola Malagutti, MD
Contact
nicolamalagutti@gmail.com
+393339011406

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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