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

NCT06749301 | Recruiting

• 1 other identifier: RS1861/23
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (1)

• Evaluation of the short-term repeatability of ADC maps in both primary and nodal lesions in patients with squamous cell carcinomas (SCC) of the head and neck

  A standardized and shared DWI acquisition protocol will be used at a multicenter level. DWI imaging consists of a spin-echo echo-planar (SE-EPI) sequence that will be acquired with 1.5 T or 3 T tomographs, setting the acquisition parameters, after the administration of the contrast medium (if any) (in order to ensure that the second DWI acquisition is performed under the same conditions as the first). The MRI study must include at least one T2-weighted axial sequence, whose images will be used to support the delineation of the lesions.

  18 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with SCC of the head and neck who, according to standard procedures, will have to undergo an MRI examination fordiagnostic purposes. Patients must also meet the inclusion criteria

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (1)

IRCCS National Cancer Institute "regina Elena"

Rome, 00144, Italy

RECRUITING

Central Study Contacts

Simona Marzi, Doctor

CONTACT

+39 06 526666238; simona.marzi@ifo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: September 11, 2023
• Primary Completion: March 11, 2025
• Study Completion: March 11, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

IT (1)