Immune PET and Proteomics for the Assessment of Response to Spatially Fractionated or Palliative Radiotherapy With or Without Immunotherapy
NCT ID: NCT06976021
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-06-30
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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SFRT with immunotherapy
Baseline 89-Zr Pembrolizumab Immuno PET-CT
Diagnostic imaging with novel radiotracer - drug (Pembrolizumab) labeled with zirconium-89
Proteomic assay
Assessment of the proteomic profile before and periodically after treatment
SHORT with immunotherapy
Baseline 89-Zr Pembrolizumab Immuno PET-CT
Diagnostic imaging with novel radiotracer - drug (Pembrolizumab) labeled with zirconium-89
Proteomic assay
Assessment of the proteomic profile before and periodically after treatment
SFRT
Baseline 89-Zr Pembrolizumab Immuno PET-CT
Diagnostic imaging with novel radiotracer - drug (Pembrolizumab) labeled with zirconium-89
Proteomic assay
Assessment of the proteomic profile before and periodically after treatment
Follow-up 89-Zr Pembrolizumab Immuno PET-CT
Diagnostic imaging with novel radiotracer - drug (Pembrolizumab) labeled with zirconium-89 after radiotherapy performed in patients who are not treated with immunotherapy
SHORT
Baseline 89-Zr Pembrolizumab Immuno PET-CT
Diagnostic imaging with novel radiotracer - drug (Pembrolizumab) labeled with zirconium-89
Proteomic assay
Assessment of the proteomic profile before and periodically after treatment
Follow-up 89-Zr Pembrolizumab Immuno PET-CT
Diagnostic imaging with novel radiotracer - drug (Pembrolizumab) labeled with zirconium-89 after radiotherapy performed in patients who are not treated with immunotherapy
Interventions
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Baseline 89-Zr Pembrolizumab Immuno PET-CT
Diagnostic imaging with novel radiotracer - drug (Pembrolizumab) labeled with zirconium-89
Proteomic assay
Assessment of the proteomic profile before and periodically after treatment
Follow-up 89-Zr Pembrolizumab Immuno PET-CT
Diagnostic imaging with novel radiotracer - drug (Pembrolizumab) labeled with zirconium-89 after radiotherapy performed in patients who are not treated with immunotherapy
Eligibility Criteria
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Inclusion Criteria
2. Patients nnot eligible for radical treatment with radiotherapy (including stereotactic radiotherapy of the tumor in the potential planned area of irradiation in the study), chemotherapy and palliative immunotherapy in accordance with applicable national standards but who qualify for palliative radiation treatment
3. General condition according to Karnofsky scale: 60-100
4. Patients with tumor (index lesion) larger than 5 cm in size that can be irradiated with either SHORT or SFRT technique (presence of other tumors that may be independently treated locally is not an exclusion criterion)
5. The tumor may be assessed using iRECIST
6. Age over 18 years
7. Granted written, informed consent to participate in the research experiment
8. No contraindications to treatment with Pembrolizumab (according to the information provided in the product characteristics).
9. Expected survival time over 6 months.
Exclusion Criteria
2. Contraindications to Pembrolizumab according to the product characteristics
3. Pregnancy and lactation
4. Inability of the patient to cooperate, including claustrophobia that prevents imaging tests from being performed as planned.
5. Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout treatment and for 5 months after its completion.
6. Condition after organ transplantation
18 Years
ALL
No
Sponsors
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Maria Sklodowska-Curie National Research Institute of Oncology
OTHER
Responsible Party
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Principal Investigators
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Sławomir Blamek, MD, PhD, MBA
Role: PRINCIPAL_INVESTIGATOR
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Central Contacts
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Other Identifiers
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23/ABM/01/00078
Identifier Type: -
Identifier Source: org_study_id
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