Immune PET and Proteomics for the Assessment of Response to Spatially Fractionated or Palliative Radiotherapy With or Without Immunotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Baseline 89-Zr Pembrolizumab Immuno PET-CT, Proteomic assay, Follow-up 89-Zr Pembrolizumab Immuno PET-CT.
- Who it may be relevant to
- Registry conditions: Triple Negative Breast Cancer, Uterine Cervical Cancer, Uterine Corpus Cancer, Malignant Melanoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
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
Primary outcome measures
- Change in expression of PD-1 receptors expressed as a ratio of SUV values [Time frame: one year]
- Change in number of areas with PD-1 receptors expressed as number of lesions [Time frame: one year]
- Change of proteome expression profile after treatment expressed in NPX (Normalized Protein eXpression) values [Time frame: one year]
Eligibility criteria
Inclusion criteria
- Pathologically confirmed diagnosis of clear cell renal cell carcinoma, melanoma, cervical cancer, endometrial cancer or triple negative breast cancer.
- 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
- General condition according to Karnofsky scale: 60-100
- 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)
- The tumor may be assessed using iRECIST
- Age over 18 years
- Granted written, informed consent to participate in the research experiment
- No contraindications to treatment with Pembrolizumab (according to the information provided in the product characteristics).
- Expected survival time over 6 months.
Exclusion criteria
- Lack of consent to participate in the experiment
- Contraindications to Pembrolizumab according to the product characteristics
- Pregnancy and lactation
- Inability of the patient to cooperate, including claustrophobia that prevents imaging tests from being performed as planned.
- 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.
- Condition after organ transplantation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06976021 · 23/ABM/01/00078