NCT05707078

Brief Summary

PET/CT follow up for Head and Neck Squamous Cell Carcinoma The following is a presentation of a prospective protocol, named PET/CT follow up for Head and Neck Squamous Cell Carcinoma (PET Follow), including patients who have completed radiotherapy treatment for squamous cell carcinoma of the head and neck (HNSCC). The purpose of this study is to investigate the diagnostic performance of 18F-fluorodeoxy-D-glucose (FDG) Positron Emission Tomography/ Computed Tomography (PET/CT) in patients with HNSCC after curative intended treatment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
56mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Mar 2023Dec 2030

First Submitted

Initial submission to the registry

January 20, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 7, 2023

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2030

Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

5.8 years

First QC Date

January 20, 2023

Last Update Submit

April 2, 2025

Conditions

Head and Neck Squamous Cell CarcinomaPET/CT

Keywords

PET/CTHNSCC

Outcome Measures

Primary Outcomes (1)

  • Number of patients with malignant lymph nodes

    Number of lymph nodes with vital tumor cells

    2 weeks

Study Arms (1)

Surgery

OTHER

Based on PET/CT scan patients will undergo neck dissection.

Procedure: Neck dissection

Interventions

Neck dissectionPROCEDURE

Based on PET/CT scan patients will undergo neck dissection.

Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent
  • Age above 18
  • Completed curative treatment for HNSCC of the oral cavity, nasopharynx, oropharynx, hypopharynx or larynx

You may not qualify if:

  • Patient refusal
  • Patients with clinical N0 neck
  • Patients who had neck dissections prior to radiotherapy
  • Patients who are clinical inoperable for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Otorhinolaryngology, Head & Neck Surgery and Audiology, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Neck Dissection

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Lymph Node ExcisionSurgical Procedures, OperativeOtorhinolaryngologic Surgical Procedures

Central Study Contacts

Jacob H Rasmussen, MD; PhD

CONTACT

+4535453251jacob.hoeygaard.rasmussen.01@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 20, 2023

First Posted

January 31, 2023

Study Start

March 7, 2023

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2030

Last Updated

April 6, 2025

Record last verified: 2025-04

Locations

DK(1)