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

May 8, 2025 updated by: Maria Sklodowska-Curie National Research Institute of Oncology

Immune PET and Proteomics for the Assessment of Response to Spatially Fractionated or Palliative Radiotherapy With or Without Immunotherapy Ocena Efektu immunomodulującego Radioterapii Paliatywnej, w Tym Radioterapii z Przestrzennym zróżnicowaniem Dawki, Podanej Samodzielnie Lub z immunoterapią, u Chorych którzy Wyczerpali możliwość Leczenia Systemowego i Radioterapii Radykalnej, Przy Wykorzystaniu Immuno-PET i badań Proteomicznych

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Pathologically confirmed diagnosis of clear cell renal cell carcinoma, melanoma, cervical cancer, endometrial cancer or triple negative breast cancer.
  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

  1. Lack of consent to participate in the experiment
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SFRT with immunotherapy
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
Active Comparator: SHORT with immunotherapy
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
Experimental: SFRT
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
Active Comparator: SHORT
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in expression of PD-1 receptors expressed as a ratio of SUV values
Time Frame: one year
The expression of PD-1 receptors will be measured with Immuno-PET basing on Zr-89 labeled Pembrolizumab and expressed as the ratio of initial and post-treatment SUV
one year
Change in number of areas with PD-1 receptors expressed as number of lesions
Time Frame: one year
The localization of regions expressing PD-1 receptors will be identified with Immuno-PET basing on Zr-89 labeled Pembrolizumab and expressed as the number of lesions
one year
Change of proteome expression profile after treatment expressed in NPX (Normalized Protein eXpression) values
Time Frame: one year
The difference between proteome expression profile before treatment and after the last infusion of Pembrolizumab or after a year in arms without immunotherapy. The Proximity Extension Assay (PEA) technology will be used. Following sequencing, the raw data will be converted to counts, assigning an integer value to each assay-sample combination based on the detected copy numbers. These raw data counts will be converted into NPX values, enabling the identification of protein level changes within different sample sets, and establishing protein signatures.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

April 27, 2025

First Submitted That Met QC Criteria

May 8, 2025

First Posted (Actual)

May 16, 2025

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 8, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23/ABM/01/00078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The individual patient data can be shared upon request. The basic demographic data, type of intervention and outcome measures will be available.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Clear Cell Renal Cell Carcinoma

Clinical Trials on Baseline 89-Zr Pembrolizumab Immuno PET-CT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe