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Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer | Clinical Trials | Clareo Health

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Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer

Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer in Head & Neck, Lung, Oesophagus, Anal Canal and Uterine Cervix - a Basis for Personalised Radiotherapy

NCT02379039•Umeå University

View on ClinicalTrials.gov

Summary

The study's aim is to define imaging and molecular bio-markers for prediction of radiotherapy response of squamous cell carcinomas, in an early treatment phase.

Detailed Description

Patients with squamous cell carcinoma of the head \& neck, anal canal, cervix, esophagus or lung will be assessed before start of radiotherapy and 1-2 weeks after start. Multi-parametric MRI and 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) will be performed in parallel to metabolomic analyses of tumour tissue. The investigators will correlate changes in imaging bio-markers to corresponding changes in tissue or blood bio-markers by repeated imaging and biopsies for better understanding of the image parameters. The data from the two assessments will be used for identifying imaging bio-markers, predictive for outcome. The patient data will be divided into one set of data for hypothesis generation and another set for validation.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Morphologically (pathology or cytology) verified, previously untreated squamous cell carcinoma (SCC) of the oral cavity, oropharynx, uterine cervix, oesophagus or lung.
•2. The patient should be planned for treatment with radiotherapy alone or in combination with concomitant medical therapy
•3. The tumour shall be radiologically and/or visually identifiable and accessible for biopsy without the need for general anaesthesia or other major interventions
•4. The patient must be at least 18 years of age, able to understand the given information and, leave a written informed consent to participate

Exclusion Criteria

•1. The patient is unwilling to participate in the study
•2. Patients with adjuvant post-operative radiotherapy (i.e. no visible remaining tumour)
•3. Pregnancy or lactation
•4. Contraindications to investigations with MRI, gadolinium contrast or PET-tracers
•5. Patients with an estimated glomerular filtration rate (GFR) \<60 ml/min/1.73m2.
•6. Severe co-morbidities that are judged to significantly compromise survival in a two-years perspective.

Locations (1)

Umeå University

Umeå, Sweden

Key Dates

Start Date

May 1, 2015

Primary Completion Date

May 1, 2023

Completion Date

May 1, 2023

Last Updated

December 22, 2023

Enrollment

118

ACTUAL participants

Conditions

Squamous CarcinomaHead and Neck CancerAnal CancerLung CancerEsophageal CancerCervix Cancer

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RECRUITINGPHASE1/PHASE2

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

NCT04585750

Advanced Solid TumorAdvanced Malignant Neoplasm+28 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer

Inclusion Criteria

Exclusion Criteria

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