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Immune PET and Proteomics for the Assessment of Response to Spatially Fractionated or Palliative Radiotherapy With or Without Immunotherapy

NCT06976021 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-16

No results posted yet for this study

Summary

The aim of the study is to evaluate the response to four schemes of treatment with novel diagnostic tools - Immuno-PET and proteomics as well as standard imaging (magnetic resonsonce imaging and computed tomography). Two fractionation schedules of radiotherapy will be used. The first will be a common standard of palliative irradiation - 20 Gy delivered in five fractions of 4 Gy (SHORT). The other is called Spatially Fractionated Radiotherapy (SFRT). SFRT is delivered in one fraction of 20 Gy but the dose is diversified inside the tumor to produce areas of high and low doses distributed alternately. This kind of irradiation may be able to stimulate immune response and improve the efficiency of immunotherapy. A drug belonging to the class of immunotherapeutic agents - Pembrolizumab will be added to the treatment scheme in two arms of the study to check that assumption. The response of the target tumor will be evaluated with PET study using Pembrolizumab labeled with zirconium-89 which will show the spatial distribution of immune receptors within the target tumor and other involved sites if there are any. The examination will be repeated after the treatment to evaluate changes in distribution of the immune receptors necessary for the drug to work. Additionally, the researchers will repeatedly test the presence and concentration of a wide panel of proteins in blood to evaluate response to the treatment more precisely.

Conditions

Interventions

DIAGNOSTIC_TEST

Baseline 89-Zr Pembrolizumab Immuno PET-CT

Diagnostic imaging with novel radiotracer - drug (Pembrolizumab) labeled with zirconium-89

DIAGNOSTIC_TEST

Proteomic assay

Assessment of the proteomic profile before and periodically after treatment

DIAGNOSTIC_TEST

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

Sponsors & Collaborators

  • Maria Sklodowska-Curie National Research Institute of Oncology

    lead OTHER

Principal Investigators

  • Sławomir Blamek, MD, PhD, MBA · Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2029-12-31
Completion
2029-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06976021 on ClinicalTrials.gov