Novel Ga68-PSMA PET/CT-tracer to Differentiate Between Radiation Necrosis and Tumor Progression in Brain Metastases
Novel Ga68-PSMA PET/CT-tracer to Differentiate Between Radiation Necrosis and Tumor Progression in Stereotactic Irradiated Brain Metastases: a Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
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:
1. 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dieta Brandsma, MD, PhD
Study Contact Backup
- Name: Lente Kroon, MD
- Phone Number: 0031205129111
- Email: neurologie@nki.nl
Study Locations
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-
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Amsterdam, Netherlands, 1066 CX Amsterdam
- Recruiting
- Netherlands Cancer Institute - Antoni van Leeuwenhoek
-
Contact:
- Dieta Brandsma, MD, PhD
-
Contact:
- Lente Kroon, MD
- Phone Number: 0205129111
- Email: neurologie@nki.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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:
- 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).
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Additional novel PET/CT
Additional novel PET/CT scan compared to standard-of-care
|
PET/CT 45 minutes after intravenous administration of 100MBq Gallium-68 labelled PSMA-11 ([68Ga]Ga-PSMA-11)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tracer Uptake (SUVpeak) on PSMA PET/CT in Brain Lesions
Time Frame: Baseline
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Quantitative tracer uptake (SUVpeak) measured on PSMA PET/CT in lesions classified as brain metastases, radiation necrosis, or diagnostic dilemma lesions.
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Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative Visual Assessment of Brain Lesions on PSMA PET/CT
Time Frame: Baseline
|
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.
|
Baseline
|
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Overall Visual Classification of Brain Lesions on PSMA PET/CT
Time Frame: Baseline
|
Overall lesion classification based on combined qualitative visual assessment criteria.
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dieta Brandsma, MD, PhD, Antoni Van Leeuwenhoek Ziekenhuis
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N18PET
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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