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Repeatability and Reproducibility of the ADC Map in Head and Neck Cancer. Prospective Multicenter Study

NCT ID: NCT06749301

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-11

Study Completion Date

2025-03-11

Brief Summary

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Evaluation of the repeatability and reproducibility of ADC maps in both primary and non-primary lesions lymph nodes in patients with head and neck cancer, using an acquisition protocol Standardized DWI

Detailed Description

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DWI imaging consists of a spin-echo echo-planar sequence (SE-EPI) that will be acquired with 1.5 T or 3 T tomographs according to the equipment of the individual centers involved, setting the acquisition parameters after the administration of any contrast medium.

Conditions

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Head and Neck Carcinoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with primary squamous cell carcinoma (SCC) of the hypopharynx, oropharynx, or oral cavity c

Patients over 18 years of age with primary squamous cell carcinoma of the head and neck (hypopharynx, oropharynx or oral cavity, confirmed by histology) will be prospectively enrolled and, according to standard procedures, will have to undergo an MRI examination for diagnostic purposes.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* age over 18 years;
* primary squamous cell carcinoma (SCC) of the hypopharynx, oropharynx, or oral cavity; confirmed by histology;
* a lesion visible on at least three consecutive DWI images, with a minimum diameter of 2 cm;
* specific written informed consent;

Exclusion Criteria

* incomplete acquisition of DWI images;
* presence of artifacts that do not allow quantitative analysis of DWI images;
* performance status 2 or more according to Zubrod.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regina Elena Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS National Cancer Institute "regina Elena"

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Simona Marzi, Doctor

Role: CONTACT

Phone: +39 06 526666238

Email: [email protected]

Facility Contacts

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Simona Marzi, Doctor

Role: primary

Other Identifiers

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RS1861/23

Identifier Type: -

Identifier Source: org_study_id