Novel Ga68-PSMA PET-tracer to differentiate between radiation necrosis and tumor progression in stereotactic irradiated brain metastases. A feasibility study.

Novel Ga68-PSMA PET-tracer to differentiate between radiation necrosis and tumor progression in stereotactic irradiated brain metastases. A feasibility study. - Ga68-PSMA in brain metastases

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54566

Enrollment

110

Registered

2019-04-08

Start date

2019-12-24

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain metastases breast cancer lungcancer melanoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: For all groups:Written informed consentAge = 18 yearsWHO Performance Status 0–3Measurable lesion =10 mm according to RANO-BM criteriaFor groups 1, 2, and 7:Newly diagnosed brain metastases (BM) from either non-small cell lung cancer (NSCLC) (group 1), melanoma (group 2), or breast cancer (group 7)For groups 3, 4, and 8:Brain lesion at the location of a formerly BM that has been treated with SRT (> 9 months ago), with the definite diagnosis of RN at the location of formerly  SRT-treated BM of NSCLC (group 3), melanoma (group 4) and breast cancer (group 8). For groups 5, 6, and 9:Brain lesion at the location of a formerly BM in  which the diagnostic dilemma of RN and recurrent BM of NSCLC (group 5),  melanoma (group 6) or breast cancer (group 9).

Exclusion criteria

Exclusion criteria: For all groups:Known allergy to Ga68-PSMAEpileptic seizure less than 7 days before Ga68-PSMA PET/CT scanLife expectancy less than 3 months Patients with known prostate carcinomaPregnancy

Design outcomes

Primary

Measure	Time frame
For group 1, 2 and 7 the sensitivity (ability of the test to correctly identify those patients with the disease) of the Ga68-PSMA brain imaging will be determined. For group 3, 4 and 8 the specificity (the ability of the test to correctly diagnose those patients without the disease) of the Ga68-PSMA brain imaging will be determined. In case the study for research question 1 shows Ga68-PSMA uptake in 70% of the cases, we can continue studying research question 2. In case there is no or a low Ga68-PSMA uptake in the patients with RN (research question 2), we will continue with the study in patients with irradiated BM, in whom there is a true dilemma whether there is RN or tumor progression (research question 3). For group 5, 6 and 9, the sensitivity and specificity will be determined. In case Ga68-PSMA brain imaging can diagnose in RN vs tumor progression in 7 of 10 patients (per tumor type) in a correct way, a future clinical diagnostic study with higher patient numbers will be initiated.	—

Measure

Time frame

For group 1, 2 and 7 the sensitivity (ability of the test to correctly identify those patients with the disease) of the Ga68-PSMA brain imaging will be determined. For group 3, 4 and 8 the specificity (the ability of the test to correctly diagnose those patients without the disease) of the Ga68-PSMA brain imaging will be determined. In case the study for research question 1 shows Ga68-PSMA uptake in 70% of the cases, we can continue studying research question 2. In case there is no or a low Ga68-PSMA uptake in the patients with RN (research question 2), we will continue with the study in patients with irradiated BM, in whom there is a true dilemma whether there is RN or tumor progression (research question 3). For group 5, 6 and 9, the sensitivity and specificity will be determined. In case Ga68-PSMA brain imaging can diagnose in RN vs tumor progression in 7 of 10 patients (per tumor type) in a correct way, a future clinical diagnostic study with higher patient numbers will be initiated.

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Countries

Netherlands

Contacts

Public ContactR Steenhuis

Antoni van Leeuwenhoek (AVL)

r.steenhuis@nki.nl0205129111

Outcome results