Advanced PET and MRI techniques for improved therapy response assessment in diffuse large B-cell lymphoma / follicular lymphoma grade 3B

Advanced PET and MRI techniques for improved therapy response assessment in diffuse large B-cell lymphoma / follicular lymphoma grade 3B - MITRAL; molecular imaging techniques for response assessment in lymphoma

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40554

Enrollment

110

Registered

2013-07-25

Start date

2013-11-13

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

Diffuse large B-cell lymphoma / follicular lymphoma grade 3B

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Male or female patients - Age: 18 years and older - Histologically proven diffuse large B-cell lymphoma / Follicular lymphoma grade 3B - Patients scheduled to undergo front-line R-CHOP 21 therapy - 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 for MRI (including cardiac pacemakers and claustrophobia). - 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. - Diffuse large B-cell lymphoma / follicular lymphoma grade 3B central nervous system involvement. - Diffuse large B-cell lymphoma / follicular lymphoma grade 3B stage I disease. - HIV positivity (de novo or active) - Pregnant or lactating women. - Therapy has already started before pretreatment dual-time point 18F-FDG PET and DWI scans could be performed.

Design outcomes

Primary

Measure	Time frame
The first outcome parameter will be the diagnostic performance of interim conventional 18F-FDG PET, dual time-point 18F-FDG PET, and DWI in detecting residual tumor after two cycles of R-CHOP in conventional interim 18 F-FDG PET positive patients, using biopsy results as reference standard. The second outcome parameter will be the diagnostic performance of 89Zr-rituximab PET in determining status of CD20 expression, using biopsy results as reference standard. The third outcome parameter will be the diagnostic performance of interim conventional 18F-FDG PET, dual time-point 18F-FDG PET, DWI, and 89Zr-rituximab PET in predicting end-of-treatment 18F-FDG PET result and disease relapse within two years.	—

Measure

Time frame

The first outcome parameter will be the diagnostic performance of interim conventional 18F-FDG PET, dual time-point 18F-FDG PET, and DWI in detecting residual tumor after two cycles of R-CHOP in conventional interim 18 F-FDG PET positive patients, using biopsy results as reference standard. The second outcome parameter will be the diagnostic performance of 89Zr-rituximab PET in determining status of CD20 expression, using biopsy results as reference standard. The third outcome parameter will be the diagnostic performance of interim conventional 18F-FDG PET, dual time-point 18F-FDG PET, DWI, and 89Zr-rituximab PET in predicting end-of-treatment 18F-FDG PET result and disease relapse within two years.

—

Secondary

Measure	Time frame
n.v.t.	—

Countries

Netherlands

Outcome results