Brain MetastasesGK-ASLNCT04833335
ASL in Brain Metastasis MRI Following Gamma Knife Treatment
A study testing MRI perfusion sequence in people with Brain Metastases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Arterial spin labeling (ASL) is a non-invasive MRI technique that could help the radiologists to distinguish brain metastasis progression versus radionecrosis following gamma-knife treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- MRI perfusion sequence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2023to 24 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Brain metastasis from histologically proven tumor
- GK treatment within 4 month prior to the inclusion
- Lesions suspected of progression/ radionecrosis :
- i.e.≥ 25% of the size progression
- Lesion size: gadolinium enhanced part of the tumour ≥1 cm
Who cannot join
- Pregnancy
- Medical history of primitive brain tumour
- MRI incompatibility/ medical history of contrast agent allergy
- Claustrophobia
- Patient unable to consent
- Epilepsia/recent stroke
- Patients participating in other studies
- Patients without health care insurance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de neuroradiologie, hôpital Pitié Salpêtrière
Paris, 75013
Natalia SHOR, MD, natalia.shor@aphp.fr
Nadya pyatigorskaya, MD, nadya.pyatigorskaya@aphp.fr
About this study
Official title: ASL in Diagnostics of Tumor Progression Versus Radionecrosis in Brain Metastasis Following Gamma Knife Treatment.
Arterial spin labeling (ASL) is a non-invasive MRI technique that could help the radiologists to distinguish brain metastasis progression versus radionecrosis following gamma-knife treatment.
The primary target of the study is to establish the diagnostic performances (specificity, sensitivity) of quantitative measures of ASL in brain metastases suspected of progression/radionecrosis after GK treatment
Read the detailed description
The metastasis progression versus radionecrosis following GK treatment can sometimes be difficult to distinguish. 60 patients will be included in this prospective, monocentric study. 3 MRI (baseline, 1month and 6 month follow-ups) will be performed. Two neuroradiologists will blindly analyse the MRIs comparing ASL sensibility and specificity to the standard morphological evaluation and T2 perfusion.
- Conditions
- Brain Metastases
- Being tested
- MRI perfusion sequence
- Keywords
- ASL, MRI, Metastasis, Gamma knife, Radionecrosis
- Medical subject headings
- Brain Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI perfusion sequenceOther
Also called Arterial Spin Labeling (ASL)
Quantitative analysis
| Study group | Role | What they receive |
|---|---|---|
| Adults with brain metastases treated with Gamma Knife whose lesions suggest tumor recurrence versus | Experimental | Inclusion visit, 1 month later, 6 month later Receives: Other: MRI perfusion sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of ASL quantitative analysis in brain metastasis following GK treatment : tumor perfusion with quantitative measurement (one value) of RCBF (relative cerebral blood flow) on the ASL sequence
Quantitative analysis (rCBF) of the evolution of brain metastasis between the initiation of treatment and 6 months after.
Measured: Evolution between Baseline MRI, 1 and 6 month follow up MRI
Secondary outcomes (3)
ASL Perfusion: Cerebral blood flow measurements
Measured: Baseline MRI, 1 and 6 month follow up MRI
Interreader correlation
Two neuroradiologists
Measured: Baseline MRI, 1 and 6 month follow-up MRI
Morphological analysis of the lesions
Lesion size, oedema
Measured: Baseline MRI, 1 and 6 month follow-up MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start24 Jan 2023
- Primary completion24 Sep 2028 (estimated)
- Study completion24 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833335
- Sponsor's protocol ID
- APHP190736
- Acronym
- GK-ASL
- Status last verified
- Aug 2025
- First submitted
- 19 Mar 2021
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASL in Diagnostics of Tumor Progression Versus Radionecrosis in Brain Metastasis Following Gamma Knife Treatment.
- ClinicalTrials.gov ID
- NCT04833335
- Acronym / sponsor ID
- GK-ASL / APHP190736
- Conditions
- Brain Metastases
- Keywords
- ASL, MRI, Metastasis, Gamma knife, Radionecrosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 24 Sep 2028 (estimated)
- Study completion
- 24 Sep 2028 (estimated)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Arterial spin labeling (ASL) is a non-invasive MRI technique that could help the radiologists to distinguish brain metastasis progression versus radionecrosis following gamma-knife treatment.
The primary target of the study is to establish the diagnostic performances (specificity, sensitivity) of quantitative measures of ASL in brain metastases suspected of progression/radionecrosis after GK treatment
Detailed description
The metastasis progression versus radionecrosis following GK treatment can sometimes be difficult to distinguish. 60 patients will be included in this prospective, monocentric study. 3 MRI (baseline, 1month and 6 month follow-ups) will be performed. Two neuroradiologists will blindly analyse the MRIs comparing ASL sensibility and specificity to the standard morphological evaluation and T2 perfusion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with brain metastases treated with Gamma Knife whose lesions suggest tumor recurrence versus | Experimental | Other: MRI perfusion sequenceInclusion visit, 1 month later, 6 month later |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Brain metastasis from histologically proven tumor
- GK treatment within 4 month prior to the inclusion
- Lesions suspected of progression/ radionecrosis :
- i.e.≥ 25% of the size progression
- Lesion size: gadolinium enhanced part of the tumour ≥1 cm
Key exclusion criteria (8 listed)
- Pregnancy
- Medical history of primitive brain tumour
- MRI incompatibility/ medical history of contrast agent allergy
- Claustrophobia
- Patient unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI perfusion sequenceAlso: Arterial Spin Labeling (ASL)Quantitative analysis | Other | Adults with brain metastases treated with Gamma Knife whose lesions suggest tumor recurrence versus |
Primary outcome
Diagnostic performance of ASL quantitative analysis in brain metastasis following GK treatment : tumor perfusion with quantitative measurement (one value) of RCBF (relative cerebral blood flow) on the ASL sequence
Time frame: Evolution between Baseline MRI, 1 and 6 month follow up MRI
Quantitative analysis (rCBF) of the evolution of brain metastasis between the initiation of treatment and 6 months after.
3 secondary outcomes
ASL Perfusion: Cerebral blood flow measurements
Time frame: Baseline MRI, 1 and 6 month follow up MRI
Interreader correlation
Time frame: Baseline MRI, 1 and 6 month follow-up MRI
Morphological analysis of the lesions
Time frame: Baseline MRI, 1 and 6 month follow-up MRI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI perfusion sequence in people with Brain Metastases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia SHOR, MD (+330661884335, shor.natalia@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of ASL quantitative analysis in brain metastasis following GK treatment : tumor perfusion with quantitative measurement (one value) of RCBF (relative cerebral blood flow) on the ASL sequence (time frame: Evolution between Baseline MRI, 1 and 6 month follow up MRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.