Radioablation of adrenal gland malignomas with interstitial high-dose-rate brachytherapy: efficacy and outcome

Radioablation of adrenal gland malignomas with interstitial high-dose-rate brachytherapy: efficacy and outcome - IBT Adrenal gland

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011047

Enrollment

Registered

2017-10-04

Start date

2016-11-11

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

C74.9 C64

Interventions

Group 1: First, a multi-parametric imaging of the adrenal glands will be performed according to the routine protocol. We performe irradiation employing the HDR brachytherapy technique based on a 10 Ci

Elekta/ Nucletron B.V., Veenendaal, the Netherlands). The co ordinates of the catheters in three dimensions and the tumor margin are on the basis of contrast-enhanced CT.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: principal inclusion criteria for interstitial high-dose-rate Brachytherapy are: 1) the presence of an indication for an interstitiell high-dose-rate brachytherapy of the adrenal gland 2) the presence of the written informed consent for scientific purposes (see attachement 3) 3) age > 18 years, no upper limit 4) no contraindications for CT-examination 5) no contraindications for interstitiell high-dose-rate brachytherapy of the adrenal gland -sufficient coagulation: platelet count: >50.000/nl prothrombin time: >50% - performance status (ECOG): >2 6) irresectability of adrenal gland metastases

Exclusion criteria

Exclusion criteria: absence of the written informed consent for scientific purposes (see attachement)- underaged patients- no compliance- presence of condrainications for interstitial high-dose-rate brachytherapy

Design outcomes

Primary

Measure	Time frame
The central aim of our study is to consider, whether interstitial HDR-Brachytherapy is an effective treatment for patients, who are unfit for surgical intervention. Therefore, the endpoint of the primary analysis is local tumor control (LCT). To determine this, we are going to make CT-Controls every 3 month.	—

Secondary

Measure	Time frame
Secondary endpoints are time to progression (TTP), Time to untreatable progression (TTUP), overall survival (OS) and safety variables. TTP and TTUP are going to be assessed by applying the RECIST criteria. Therefor we are going to make an imaging follow up every three month. An other instrument to asses TTP und TTUP is to determine the files notes, in terms of a significant decrease in performance status (to ECOG 3 or higher) or because of the date of death. We want to determine overall survival based on follow up imaging and date of death. We are going to asses the safety, by side effects caused by the intervention, following the CTCAE criteria.	—

Measure

Time frame

Secondary endpoints are time to progression (TTP), Time to untreatable progression (TTUP), overall survival (OS) and safety variables. TTP and TTUP are going to be assessed by applying the RECIST criteria. Therefor we are going to make an imaging follow up every three month. An other instrument to asses TTP und TTUP is to determine the files notes, in terms of a significant decrease in performance status (to ECOG 3 or higher) or because of the date of death. We want to determine overall survival based on follow up imaging and date of death. We are going to asses the safety, by side effects caused by the intervention, following the CTCAE criteria.

—

Countries

Germany

Contacts

Public ContactKonrad Mohnike

Klinik für Radiologie und NuklearmedizinUniversität Magdeburg

konrad.mohnike@med.ovgu.de+391-6713030

Outcome results

None listed

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