on-invasive MRI spectroscopy at 7 Tesla in lymphoma

Completed

Conditions: lymphoma
lymph node cancer
10025323

Registration Number: NL-OMON40364

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

- Male or female patients.
- Age: 18 years and older.
- Under high suspicion of or histologically proven, newly diagnosed or relapsed Hodgkin lymphoma or non-Hodgkin lymphoma.
- Patients are required to have an enlarged (i.e. diameter >= 2 cm) lymphomatous lymph node in a superficial region (e.g. head/neck, axial or inguinal in order to fit in the MRI spectroscopy field of view).
- Patients must be capable of giving written informed consent and the consent must have been obtained before the study-related procedures.

Exclusion Criteria

- General contraindications to MRI (claustrophobia, cardiac pacemakers, neurostimulators).
- Patients with central nervous system lymphoma.
- Previous malignancy. However, subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
- Pregnant or lactating patients.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the diagnostic accuracy of the 7T MRI spectroscopy<br /><br>biomarkers lactate and phospholipids for the differentiation between aggressive<br /><br>and indolent lymphoma. In addition, levels of lactate and phospholipids will be<br /><br>correlated with Ki-67 expression and the maximum standard uptake value (SUVmax)<br /><br>of 18F-FDG PET.<br /><br><br /><br>The secondary endpoint of this study is to determine interscan agreement (i.e.<br /><br>test-retest variability) of 7T MRI spectroscopy for assessing levels of lactate<br /><br>and phospholipids in lymphoma.<br /><br><br /><br>The tertiary endpoint is to determine the difference in lactate and<br /><br>phospholipid concentrations between two different lymph nodes.<br /><br><br /><br>The fourth endpoint is the determination of presence and degree of changes in<br /><br>levels of lactate and phospholipids after treatment relative to pretreatment<br /><br>values.</p><br>

Secondary Outcome Measures