Trial · NCT05424016
Propranolol and Von Hippel-Lindau Disease
NCT05424016, Not applicable, Unknown, Assistance Publique - Hôpitaux de Paris
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Propranolol and Von Hippel-Lindau Disease. Trials, record NCT05424016. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05424016
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Propranolol and Von Hippel-Lindau Disease
- NCT number
- NCT05424016
- Status
- Unknown
- Phases
- Not applicable
- Enrollment
- 85 participants, estimated
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Conditions
- Hemangioblastoma of CNS, Von Hippel-Lindau Disease
- Interventions
- Propranolol, follow-up
- First posted
- 2022-06-21
- Last updated
- 2023-12-13
- Other registries' IDs
- eudract:2022-001174-54
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | total and individual hemangioblastomas' volume measured by MRI | 24 months | Response to treatment at 24 months will be a binary variable (responder/non responder) using initial imaging data and 24-month post-randomization, assessed by two neuroradiologists, independently. On baseline imaging two types of CNS BHs will be defined and measured: "measurable" BHs whose largest diameter is ≥ 5 mm "Non-measurable" BHs whose largest diameter is \< 5 mm For each patient the sum of the volumes of all measurable BHs in mm3 will be calculated initially and compared to this same sum at 24 months post-randomization. A patient will be as "responder" : The sum at 24 months remains stable Or regresses No HB identified as "non-measurable" initially has reached the "measurable" criterion No de novo HBs have appeared A patient will be as "non-responder": The sum at 24 months increases At least one HB identified as "non-measurable" initially has reached the "measurable" criterion At least one de novo HB appears The patient has required surgery during follow-up |
| Secondary | To compare the safety (tolerance) between the two treatment arms at 24 months post-randomization | 24 months | To study safety (tolerability) of propranolol in VHL patients: All adverse events related to the use of Propanolol that occurred during the study will be collected, analyzed and compared between the two treatment arms |
| Secondary | To Compare the growth rate of HB between the two treatment arms at 24 months post-randomization | 24 months | To compare HB growth rate between the two treatment arms at 24 months post-randomization: HB growth rate will be measured on each MRI by two neuroradiologists, blinded to the randomization arm. It will be calculated in mm3 /month using the function available on the ITK-SNAP imaging software ( www.itksnap.org.) which allows an accurate measurement of the tumor volume (In case of disagreement a conciliation session will be organized). The growth rate is therefore obtained by dividing the change in volume by the number of months between the two MRIs |
| Secondary | Compare the extent of peritumoral edema between the two treatment arms | 24 months | To compare the extent of peritumoral edema between the two treatment arms: The size of peritumoral edema will be measured on each MRI by two neuroradiologists, blinded to the randomization arm |
| Secondary | Compare the development of de novo lesions between the two treatment arms every 6 months | 24 months | To compare the occurrence of de novo lesions between the two treatment arms: the number of de novo HBs will be specified for each patient at each follow-up MRI by two neuroradiologists, blinded to the randomization arm. A de novo HB is defined as the appearance during follow-up of a HB that did not exist on the initial imaging (or the transition from a non-measurable HB to a measurable state |
| Secondary | Compare the angiogenic profile of BHs between the two groups every 6 months | 24 months | To compare the angiogenic profile of BHs between the two groups by perfusion sequence with r-CBV measurement for each measurable and perfusion-studyable lesion (\> 1cm) |
| Secondary | Study the evolution of serum VEGF level under treatment at 12 and 24 months | 24 months | To study the evolution of serum VEGF level under treatment: Determination of serum VEGF level at the beginning of the treatment and then at 12 and 24 months by a simple peripheral venous blood sample. (pg/ml) |
| Secondary | Compare the number of patients requiring surgery between the two treatment arms | 24 months | To compare the number of patients requiring surgery between the two treatment arms: The use of surgery will be recorded during patient follow-up (use/non-use). The need for surgery will be left to the discretion of the physician responsible for the patient's follow-up |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05424016
GET https://conductscience.org/api/trials/v1/NCT05424016/registered