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AROMA - Impact of radioembolization of hepatic malignomas on distal not irradiated tumor tissue.

AROMA - Impact of radioembolization of hepatic malignomas on distal not irradiated tumor tissue. - AROMA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00009744
Enrollment
100
Registered
2016-03-04
Start date
2016-03-04
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

C20 C19 C18

Interventions

Group 1: To obtain data concerning systemic release of growth factors and immunogenic factors after radioembolization of hepatic tumors (colorectal cancer).

Sponsors

Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: •hepatic metastatic colorectal carcinoma •male/female, 18+ •Indication for radioembolization and HDR-brachytherapy in two sessions •informed consent •chemotherapy break for at least 2 weeks before inclusion •no corticosteroides for at least 2 weeks before inclusion

Exclusion criteria

Exclusion criteria: •life expectancy 70% •chronic infections •ascites •contraindication for angiography, MRI contrast media, X-ray contrast media, MRI and CT •liver cirrhosis •condition after resection of the papilla vateri or DHC stenting •cardio vascular disease (NYHA III/IV) •thrombotic/embolic episodes (stroke) •severe hemorrhages within last 3 month •secondary malignoma within last 5 years •immune suppressive therapy or disease (e.g. condition after organ transplantation, HIV, corticosteroides) •autoimmune disease or inflammatory bowel disease

Design outcomes

Primary

MeasureTime frame
Comparison of the amount of tumor infiltrating lymphocytes before and 4-8 weeks after radioembolization of hepatic tumors in not yet treated tumor sites. Determination of the level of systemcally released growth factors after radioembolization of hepatic tumors and correlation with growth tendency of not yet treated tumor parts in the treatment free intervall between radioembolization and brachytherapy.

Secondary

MeasureTime frame
-Analyses of peripheral circulation lymphozytes -Receptorexpression on tumor cells before and after radioembolization

Countries

Germany

Contacts

Public ContactChristel Besseler

Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern

christel.besseler@med.uni-muenchen.de(089) 4400-73647

Outcome results

None listed

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