MR imaging biomarkers associated with patient-reported xerostomia post-RT

MR imaging biomarkers associated with patient-reported xerostomia post-RT - BOCASEcA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54312

Enrollment

Registered

2021-07-12

Start date

2022-05-20

Completion date

Unknown

Last updated

2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Speekselklier schade naar aanleiding van hoofdhals radiotherapie dry mouth syndrome Xerostomia

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: • The patients are above 18 years old and have received (chemo)radiotherapy for primary H&N cancer with curative intent. • Patients can be enrolled after completion of their radiotherapy treatment months from 6 months up to 3 years. • The patients have no previous history of surgery in H&N region. • The patients have provided written informed consent before inclusion in the study.

Exclusion criteria

Exclusion criteria: • The patients have adverse-indication for an MRI scan, such as claustrophobia, pregnancy, pacemaker or implantable defibrillator, metal implants. • Patients with psychological or somatic disorders, limiting the possibilities for adequate follow-up.

Design outcomes

Primary

Measure	Time frame
Primary Objective: To determine the difference of the apparent diffusion coefficient (ADC) mean values and ADC histograms of the salivary glands at rest, between H&N cancer patients reporting late toxicity (grade 2 or higher) of xerostomia, and those reporting no late toxicity. Late toxicity is occurring >=6 months after completion of radiation therapy (RT).	—

Secondary

Measure	Time frame
Secondary Objectives: 1. To determine the difference of the ADC mean values and ADC histograms of the salivary glands after gustatory stimulation, between H&N cancer patients reporting late toxicity (grade 2 or higher) of xerostomia, and those reporting no late toxicity. 2. To determine the difference of the Fat Fraction (FF) and T1/T2 maps values of the salivary glands between H&N cancer patients reporting late toxicity (grade 2 or higher) of xerostomia, and those reporting no late toxicity. 3. To compare the visibility of the major salivary ducts at rest and after gustatory stimulation between H&N cancer patients reporting late toxicity (grade 2 or higher) of xerostomia, and those reporting no late toxicity. 4. To investigate associations of the MRI imaging biomarkers studied with self-reported patient symptoms of sticky saliva and swallowing dysfunction, as reported by the patients in the QoL H&N43 questionnaire, and determine intercorrelation between these symptoms. 5. To determine the reproducibility of the primary and secondary objectives, 1 to 3, a 2de MRI will be performed to a subgroup of patients and test retest analysis will be done	—

Measure

Time frame

Secondary Objectives: 1. To determine the difference of the ADC mean values and ADC histograms of the salivary glands after gustatory stimulation, between H&N cancer patients reporting late toxicity (grade 2 or higher) of xerostomia, and those reporting no late toxicity. 2. To determine the difference of the Fat Fraction (FF) and T1/T2 maps values of the salivary glands between H&N cancer patients reporting late toxicity (grade 2 or higher) of xerostomia, and those reporting no late toxicity. 3. To compare the visibility of the major salivary ducts at rest and after gustatory stimulation between H&N cancer patients reporting late toxicity (grade 2 or higher) of xerostomia, and those reporting no late toxicity. 4. To investigate associations of the MRI imaging biomarkers studied with self-reported patient symptoms of sticky saliva and swallowing dysfunction, as reported by the patients in the QoL H&N43 questionnaire, and determine intercorrelation between these symptoms. 5. To determine the reproducibility of the primary and secondary objectives, 1 to 3, a 2de MRI will be performed to a subgroup of patients and test retest analysis will be done

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Countries

Netherlands

Outcome results