Brain Metastases From Non-small Cell Lung Cancer (NSCLC)NCT07511933
Novel Ga68-PSMA PET/CT-tracer to Differentiate Between Radiation Necrosis and Tumor Progression in Brain Metastases
A study testing 86-Gallium PSMA PET/CT in people with Brain Metastases From Non-small Cell Lung Cancer (NSCLC) and Brain Metastases From Melanoma, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
This study aims to evaluate the diagnostic potential of 68-Gallium PSMA-PET/CT in stereotactic irradiated brain metastases from non-small cell lung cancer, melanoma and breast cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Metastases From Non-small Cell Lung Cancer (NSCLC), Brain Metastases From Melanoma, Brain Metastases From Breast Cancer
- What is being tested?
- 86-Gallium PSMA PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Dec 2019to 1 Jul 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For all groups:
- Written informed consent
- Age ≥ 18 years old
- WHO PS 0-3
- Measurable lesion ≥10mm according to RANO BM
- For brain metastases groups:
Show all 11Show fewer
- newly diagnosed brain metastases from either NSCLC (group 1) or melanoma (group 2) or breast cancer (group 7).
- For radiation necrosis groups:
- Brain lesion at the location of a formerly brain metastases that has been treated with SRT (> 9 months ago), with the definite diagnosis of radiation necrosis at the location of formerly SRT-treated brain metastases of NSCLC (group 3), melanoma (group 4) and/ or breast cancer (group 8).
- For diagnostic dilemma groups:
- Brain lesion at the location of a formerly brain metastases with a diagnostic dilemma of radiation necrosis and recurrent brain metastases of NSCLC (group 5), melanoma (group 6) and/ or breast cancer (group 9).
Who cannot join
- For all groups:
- Known allergy to Ga68-PSMA
- Epileptic seizure less than 7 days before Ga68-PSMA PET/CT scan
- Life expectancy less than 3 months
- Patients with known prostate carcinoma
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dieta Brandsma, MD, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam, 1066 CX Amsterdam
Lente Kroon, MD, 0205129111, neurologie@nki.nl
Dieta Brandsma, MD, PhD
About this study
Official title: Novel Ga68-PSMA PET/CT-tracer to Differentiate Between Radiation Necrosis and Tumor Progression in Stereotactic Irradiated Brain Metastases: a Feasibility Study
This study aims to evaluate the diagnostic potential of 68-Gallium PSMA-PET/CT in stereotactic irradiated brain metastases from non-small cell lung cancer, melanoma and breast cancer.
Read the detailed description
This prospective phase II diagnostic feasibility study investigates the diagnostic potential of 68-Gallium PSMA-PET/CT in stereotactic irradiated brain metastases from non-small cell lung cancer, melanoma and breast cancer.
Participants will be enrolled in three predefined cohorts per primary tumor type:
- newly diagnosed brain metastases,
- definite radiation necrosis, and
- diagnostic dilemma after radiotherapy.
The goals of this study are:
- Evaluating PSMA expression using Ga68-PSMA PET/CT in brain metastases of NSCLC, breast cancer and melanoma patients eligible for stereotactic radiotherapy (SRT) or surgery. 2. Evaluating PSMA expression using Ga68-PSMA PET/CT in patients with definite radiation necrosis. 3. Evaluating the use of Ga68-PSMA PET/CT to differentiate progressive brain metastases of NSCLC, breast cancer and/ or melanoma from radiation necrosis by quantifying PSMA activity.
- Conditions
- Brain Metastases From Non-small Cell Lung Cancer (NSCLC), Brain Metastases From Melanoma, Brain Metastases From Breast Cancer
- Being tested
- 86-Gallium PSMA PET/CT
- Keywords
- Brain Metastases, Radiation Necrosis, Diagnostic Imaging, Radiation-induced Toxicity
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
86-Gallium PSMA PET/CTDiagnostic test
PET/CT 45 minutes after intravenous administration of 100MBq Gallium-68 labelled PSMA-11 ([68Ga]Ga-PSMA-11)
| Study group | Role | What they receive |
|---|---|---|
| Additional novel PET/CT | Experimental | Additional novel PET/CT scan compared to standard-of-care Receives: Diagnostic Test: 86-Gallium PSMA PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracer Uptake (SUVpeak) on PSMA PET/CT in Brain Lesions
Quantitative tracer uptake (SUVpeak) measured on PSMA PET/CT in lesions classified as brain metastases, radiation necrosis, or diagnostic dilemma lesions.
Measured: Baseline
Secondary outcomes (2)
Qualitative Visual Assessment of Brain Lesions on PSMA PET/CT
Qualitative visual assessment of lesions classified as brain metastases, radiation necrosis, or diagnostic dilemma lesions on PSMA PET/CT based on lesion shape (round to spiculated), lesion margin (sharp to ill-defined), internal homogeneity (homogeneous to heterogeneous), each scored on a 5-point Likert scale; multifocality and presence of central photopenia, both scored as yes/no.
Measured: Baseline
Overall Visual Classification of Brain Lesions on PSMA PET/CT
Overall lesion classification based on combined qualitative visual assessment criteria.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start24 Dec 2019
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Metastases From Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dieta Brandsma, MD, PhD, Principal investigator, Antoni van Leeuwenhoek Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511933
- Sponsor's protocol ID
- N18PET
- Status last verified
- Jul 2026
- First submitted
- 30 Mar 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Ga68-PSMA PET/CT-tracer to Differentiate Between Radiation Necrosis and Tumor Progression in Stereotactic Irradiated Brain Metastases: a Feasibility Study
- ClinicalTrials.gov ID
- NCT07511933
- Acronym / sponsor ID
- N18PET
- Conditions
- Brain Metastases From Non-small Cell Lung Cancer (NSCLC), Brain Metastases From Melanoma, Brain Metastases From Breast Cancer
- Keywords
- Brain Metastases, Radiation Necrosis, Diagnostic Imaging, Radiation-induced Toxicity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 24 Dec 2019 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 6 Apr 2026 (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.
This study aims to evaluate the diagnostic potential of 68-Gallium PSMA-PET/CT in stereotactic irradiated brain metastases from non-small cell lung cancer, melanoma and breast cancer.
Detailed description
This prospective phase II diagnostic feasibility study investigates the diagnostic potential of 68-Gallium PSMA-PET/CT in stereotactic irradiated brain metastases from non-small cell lung cancer, melanoma and breast cancer.
Participants will be enrolled in three predefined cohorts per primary tumor type:
- newly diagnosed brain metastases,
- definite radiation necrosis, and
- diagnostic dilemma after radiotherapy.
The goals of this study are:
- Evaluating PSMA expression using Ga68-PSMA PET/CT in brain metastases of NSCLC, breast cancer and melanoma patients eligible for stereotactic radiotherapy (SRT) or surgery. 2. Evaluating PSMA expression using Ga68-PSMA PET/CT in patients with definite radiation necrosis. 3. Evaluating the use of Ga68-PSMA PET/CT to differentiate progressive brain metastases of NSCLC, breast cancer and/ or melanoma from radiation necrosis by quantifying PSMA activity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Additional novel PET/CT | Experimental | Diagnostic Test: 86-Gallium PSMA PET/CTAdditional novel PET/CT scan compared to standard-of-care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent
- Age ≥ 18 years old
- WHO PS 0-3
- Measurable lesion ≥10mm according to RANO BM
- newly diagnosed brain metastases from either NSCLC (group 1) or melanoma (group 2) or breast cancer (group 7).
Key exclusion criteria (6 listed)
- Known allergy to Ga68-PSMA
- Epileptic seizure less than 7 days before Ga68-PSMA PET/CT scan
- Life expectancy less than 3 months
- Patients with known prostate carcinoma
- Pregnancy
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 |
|---|---|---|
| 86-Gallium PSMA PET/CTPET/CT 45 minutes after intravenous administration of 100MBq Gallium-68 labelled PSMA-11 ([68Ga]Ga-PSMA-11) | Diagnostic test | Additional novel PET/CT |
Primary outcome
Tracer Uptake (SUVpeak) on PSMA PET/CT in Brain Lesions
Time frame: Baseline
Quantitative tracer uptake (SUVpeak) measured on PSMA PET/CT in lesions classified as brain metastases, radiation necrosis, or diagnostic dilemma lesions.
2 secondary outcomes
Qualitative Visual Assessment of Brain Lesions on PSMA PET/CT
Time frame: Baseline
Overall Visual Classification of Brain Lesions on PSMA PET/CT
Time frame: Baseline
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 24 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Dieta Brandsma, MD, PhD contact
Dieta Brandsma, MD, PhD principal investigator
Antoni van Leeuwenhoek Ziekenhuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 86-Gallium PSMA PET/CT in people with Brain Metastases From Non-small Cell Lung Cancer (NSCLC) and Brain Metastases From Melanoma, run by The Netherlands Cancer Institute at 1 site in Netherlands.
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 11 inclusion and 6 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 24 Jul 2026. 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 Netherlands. 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 Lente Kroon, MD (0031205129111, neurologie@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tracer Uptake (SUVpeak) on PSMA PET/CT in Brain Lesions (time frame: Baseline). 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 24 Jul 2026.