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Contrast Clearance analysis for the differentiation of treatment related progression and progressive disease of brain lesions after radiatin therapy

Contrast Clearance analysis for the differentiation of treatment related progression and progressive disease of brain lesions after radiatin therapy - CiCeRO

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00035809
Enrollment
60
Registered
2024-12-30
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

T66

Interventions

Group 1: Patients will be prospectively enrolled who, following cranial radiotherapy for known high-grade astrocytomas/glioblastomas or cerebral metastases, present with imaging findings that cannot b

Sponsors

Universitätsklinik für Radioonkologie, Universitätsklinikum Tübingen
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Diagnosis of an astrocytoma grade 3-4, glioblastoma grade 4, or cerebral metastasis of a solid tumor -Previous cranial radiotherapy -Unclear progression (true progression vs. pseudoprogression/radionecrosis) requiring further investigations (cMRI with specialized sequences, stereotactic biopsy, FET-PET) -Decision by an interdisciplinary tumor board recommending FET-PET and tissue sampling for histological clarification of the progression

Exclusion criteria

Exclusion criteria: -Contraindication to undergoing MRI -Contraindication to undergoing FET-PET -Contraindication to undergoing stereotactic biopsy

Design outcomes

Primary

MeasureTime frame
The accuracy of the CCA in distinguishing between radionecrosis and tumor progression. Measured against the gold standard (histological findings), it should achieve an accuracy of at least 70% (unacceptable outcome) and, ideally, an accuracy of 85% (promising outcome).

Secondary

MeasureTime frame
The accuracy of further examinations (FET-PET, conventional MRI, MR perfusion, MR spectroscopy) in distinguishing between radionecrosis and tumor progression. Measured against the gold standard (histological findings), it should achieve an accuracy of at least 70% (unacceptable outcome) and, ideally, an accuracy of 85% (promising outcome).

Countries

Germany

Contacts

Public ContactRaphael Bodensohn

Universitätsklinik für Radioonkologie, Universitätsklinikum Tübingen

raphael.bodensohn@med.uni-tuebingen.de070712985900

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026