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

Organizational Data

DRKS-ID:
DRKS00009744
Recruitment Status:
Recruiting complete, study continuing
Date of registration in DRKS:
2016-03-04
Last update in DRKS:
2024-02-27
Registration type:
Prospective

Acronym/abbreviation of the study

AROMA

URL of the study

No Entry

Brief summary in lay language

No Entry

Brief summary in scientific language

In sequential radioembolisation of hepatic malignomas there is an interval of 6-8 weeks between the treatments of the right and left liver lobe to prevent radiation induced liver disease. In that time frame compensational hyperthrophia of the parenchyma of the non embolised liver lobe occurs. The non treated tumorfractions behave more differentiated. In most patients non embolized metastases stay constant or present with a slight growth tendency, in some cases huge progress is reported and in really few cases there is a regress of tumor masses. The hypotheses states, that through radioembolisation of one lobe of the liver there is a release of mitogens (growth factors) through destruction of healthy parenchyma and immunogens (DAMPs (damage-associated molecular pattern molecules) through destruction of the tumor that influence the growth-pattern of residual, not yet treated tumor tissue. Mitogens promote growth (negative abscopal effect), depending on the receptor-expression of the tumor. However, immunogens induce a vaccination effect that helps to control growth through immunological and cytotoxic means (positive abscopal effect). The goal of the study is to acquire data to support one of the aforementioned hypothesis. To achieve that serological, cytological and histological factors will be tested and compared before and after radioembolisation. The investigation will be applied to patients with colorectal carcinoma who are planned for a hybrid-intervention. This entails, that one side of the liver will be treated with radioembolisation while the contralateral lobe will be treated with a CT-guided Brachytherapie(HDR) in a second session 4-8 weeks later. The hybrid intervention enables us to take the two critical biopsies before the radioembolisation (to verify diagnosis and indication) and the second during the application of catheters for brachytherapie.

Health condition or problem studied

ICD10:
C20 - Malignant neoplasm of rectum
ICD10:
C19 - Malignant neoplasm of rectosigmoid junction
ICD10:
C18 - Malignant neoplasm of colon
Healthy volunteers:
No Entry

Interventions, Observational Groups

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

Endpoints

Primary outcome:
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 outcome:
-Analyses of peripheral circulation lymphozytes -Receptorexpression on tumor cells before and after radioembolization

Study Design

Purpose:
Basic research/physiological study
Retrospective/prospective:
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Study type:
Non-interventional
Longitudinal/cross-sectional:
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Study type non-interventional:
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Recruitment

Recruitment Status:
Recruiting complete, study continuing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Klinik für Radiologie und Nuklearmedizin Magdeburg
  • University medical center Klinik und Poliklinik für Radiologie München

Recruitment period and number of participants

Planned study start date:
2016-03-04
Actual study start date:
2016-03-04
Planned study completion date:
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Actual Study Completion Date:
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Target Sample Size:
100
Final Sample Size:
64

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional 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

•life expectancy < 3 month •extrahepatic tumor manifestation •hepatic tumorload > 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

Addresses

Primary Sponsor

Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
Prof. Jens Ricke
Marchioninistr. 15
81377 München
Germany
Telephone:
(089) 4400-4400 72750
Fax:
(089) 4400-76648
Contact per E-Mail
URL:
http://www.klinikum.uni-muenchen.de/de/index.html
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinik und Poliklinik für Radiologie LMU Klinikum der Universität München
Prof. Dr. med. Max Seidensticker
Marchioninistr. 15
81377 München
Germany
Telephone:
089/4400-76642
Fax:
089/4400-76648
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
Christel Besseler
Marchioninistr. 15
81377 München
Germany
Telephone:
(089) 4400-73647
Fax:
(089) 4400-76648
Contact per E-Mail
URL:
http://intranet.klinikum.uni-muenchen.de/de/index.html

Principal Investigator

Klinik und Poliklinik für Radiologie LMU Klinikum der Universität München
Prof. Dr. med. Max Seidensticker
Marchioninistr. 15
81377 München
Germany
Telephone:
089/4400-76642
Fax:
089/4400-76648
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Klinikum der Universität München, Campus Großhadern
Marchioninistraße 15
81377 München
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.klinikum.uni-muenchen.de

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Otto-von-Guericke-Universität an der Medizinischen Fakultät und am Universitätsklinikum Magdeburg A.ö.R.
Leipziger Str. 44 Haus 28
39120 Magdeburg
Germany
Telephone:
+49-391-6714314
Fax:
+49-391-67290185
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2015-12-07
Ethics committee number:
173/15
Vote of the Ethics Committee:
Approved
Date of the vote:
2016-01-05

Other Address Ethics Committee

Ethikkommission der Med. Fakultät der LMU
Pettenkoferstraße 8
80336 München
Germany
Telephone:
+49-89-440055191
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of the Ethics Committee

Vote of the Ethics Committee:
Approved
Date of the vote:
2017-06-01

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
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Study abstract:
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Other study documents:
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Background literature:
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Related DRKS studies:
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Publication of study results

Planned publication:
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Publikationen/Studienergebnisse:
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Date of first publication of study results:
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DRKS entry published for the first time with results:
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Basic reporting

Basic Reporting / Results tables:
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Brief summary of results:
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