Non-invasive MRI spectroscopy at 7 Tesla in lymphoma

Non-invasive MRI spectroscopy at 7 Tesla in lymphoma - MRI spectroscopy in lymphoma

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40364

Enrollment

Registered

2013-08-12

Start date

2013-11-22

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

lymphoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results