Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer

  • STATUS
    Recruiting
  • End date
    May 9, 2023
  • participants needed
    412
  • sponsor
    Umeå University
Updated on 9 October 2021
cancer
medical therapy
cavities
carcinoma
squamous cell carcinoma
dental caries
cervical disease

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.

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.

Details
Condition carcinoma of the cervix uteri, lung carcinoma, oesophageal cancer, Head and Neck Cancer, cancer of the esophagus, squamous cell cancer, epidermoid carcinoma, cervix cancer, Pulmonary Disease, Esophageal Diseases, cancer of the cervix, oesophageal carcinoma, carcinoma of cervix, Carcinoma, Bronchial Neoplasm, Esophageal Cancer, Lung Neoplasm, carcinoma lung, anal carcinoma, Lung Disease, Squamous Cell Carcinoma, head and neck cancer, Rectal Cancer, Squamous cell carcinoma, Anal Cancer, Vulvar Dysplasia and Carcinoma, Uterine Cancer, esophagus cancer, Cervical Cancer, cervical cancer, uterine, Lung Cancer, Esophageal Disorders, cancer of the head and neck, cervical carcinoma, Uterine Serous Carcinoma, Esophageal Carcinoma, Disorders of cervix NOS, Advanced Malignancies, carcinoma of the cervix
Clinical Study IdentifierNCT02379039
SponsorUmeå University
Last Modified on9 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Morphologically (pathology or cytology) verified, previously untreated squamous cell carcinoma (SCC) of the oral cavity, oropharynx, uterine cervix, oesophagus or lung
The patient should be planned for treatment with radiotherapy alone or in combination with concomitant medical therapy
The tumour shall be radiologically and/or visually identifiable and accessible for biopsy without the need for general anaesthesia or other major interventions
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

The patient is unwilling to participate in the study
Patients with adjuvant post-operative radiotherapy (i.e. no visible remaining tumour)
Pregnancy or lactation
Contraindications to investigations with MRI, gadolinium contrast or PET-tracers
Patients with an estimated glomerular filtration rate (GFR) <60 ml/min/1.73m2
Severe co-morbidities that are judged to significantly compromise survival in a two-years perspective
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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