To determine the prognostic value of diffusion-weighted MRI and circulating tumor DNA (ctDNA) performed pre-treatment and during treatment in predicting the locoregional response to (chemo)radiation for HNSCC.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the predictive value of DW-MRI and ctDNA after the
start of radiotherapy based on a single scan during treatment.
Secondary outcome
ADC level and tumor volume pretreatment;
Change in ADC levels, ctDNA and gross tumor volume prior to, during and after
therapy;
The optimal time point for MRI scanning during treatment in order to predict
treatment outcome.
Background summary
The last decade, radiotherapy with or without chemotherapy has become an organ
spearing treatment modality for functionally irresectable head and neck
squamous cell carcinoma (HNSCC) to retain the best quality of life. The early
identification of non-responders to (chemo)radiation would spare a substantial
number of patients from the morbidity and the complications of salvage surgery
and in such cases may lead to overall improvements in survival if radiotherapy
is used, when indicated, as a post-operative modality
Study objective
To determine the prognostic value of diffusion-weighted MRI and circulating
tumor DNA (ctDNA) performed pre-treatment and during treatment in predicting
the locoregional response to (chemo)radiation for HNSCC.
Study design
This study is a observational study of a prospective cohort containing 100 -
120 consecutive patients, dependent on the amount of patients eligible for both
MRI and tumor DNA quantification.
Study burden and risks
In standard clinical practice these patients will undergo pretreatment MRI
including a diffusion weighted sequence. In this protocol, included patients
will undergo 4 additional MRI exams during treatment. The additional scans will
be made on the MRI-scanner at the Department of Radiotherapy. Additional
scanning time for the four MRI*s amounts to 20 minutes per exam. If patients
provide consent blood and saliva samples will be obtained pretreatment and 4
times during treatment and 1-2 times after treatment in order to examine
circulating tumor DNA. The patients have no benefit of the extra MRI
sequencesprocedures, as these scans are not used for clinical practice and
treatment related decisions. In the future patients may benefit from DW-MRI and
circulating tumor DNA quantification during treatment in stopping futile - low
chance to cure - (chemo)radiation and switch to surgical treatment with still
adjuvant radiotherapy available. This study poses no additional risk to
participating patients as DW-MRI is a conventional techniqueconventional
techniques with inherent low risk are used.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
-Squamous cell carcinoma
-T2, T3 or T4 oral cavity or pharynx
-T3 or T4 larynx
-Technically resectable
-Scheduled for primary (chemo)radiation with curative intent
-*Informed consent* signed by patient
Exclusion criteria
-Age < 18 years
-Pregnancy
-Patients unsuited for MRI examination as defined in the protocols of the
Radiology department.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL57164.041.16 |
| OMON | NL-OMON24896 |