Study to Assess Safety and PET Imaging Characteristics of a Novel Senescence-specific Radiotracer [18F]FPyGal (2-[Fluorine-18]Fluoro-3-pyridinyl-β-D-galactopyranoside) (SenPET)
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|ClinicalTrials.gov Identifier: NCT04536454|
Recruitment Status : Recruiting
First Posted : September 2, 2020
Last Update Posted : May 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: [18F]FPyGal||Phase 1 Phase 2|
The so-called tumor senescence is described as a resistance mechanism, which can be the basis for the non-response to most common chemotherapies. It is believed that the identification of so-called senescent tumors could improve treatment strategies for solid tumors and, in particular, avoid inefficient treatment of patients with highly toxic drugs.
The aim of this study is to investigate the safety, radiation exposure (dosimetry) and diagnostic accuracy of the novel diagnostic substance [18F]FPyGal if it is used before tumor imaging imaging (here: positron emission tomography combined with magnetic resonance imaging (PET / MRT) or in combination with computed tomography (PET / CT)).
Diagnostic substances used in imaging such as [18F]FPyGal are known as radiotracers, since their distribution in the tumor tissue can provide information about the special tumor biological processes taking place there.
In the context of this study, it is of particular interest to find out whether it is possible to use the novel radiotracer [18F]FPyGal to detect areas after standard tumor therapy that contain particularly resistant (therapy-resistant) tumor cells. This resistance phenomenon in tumor tissues, which may be visualized with the radiotracer [18F]FPyGal, is called tumor senescence.
The latest research results show that senescent tumor cells can not only evade different forms of chemotherapy or radiation therapy. Senescent tumor cells can also cause the cancer to come back later. That is why current therapeutic research is concentrating on developing new approaches to combat such senescent tumor cells. For this it is relevant to be able to first diagnose senescent tumor cells as well as possible using imaging.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2, Open-label Study to Assess Safety, Tolerability, Biodistribution, Radiation Dosimetry and PET Imaging Characteristics of [18F]FPyGal in Comparison to in Vitro Diagnostics for the Assessment of Senescence in Oncological Patients|
|Actual Study Start Date :||April 28, 2021|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2024|
Cancer patients will first be treated with a tumor type-specific neo-adjuvant chemotherapy regimen (standard-of-care); subsequently, they will undergo surgical resection of their primary tumors in a curative intention.
After the end of the neo-adjuvant therapy a tracer injection with [18F]FPyGal solution will be administered (study intervention). Immediately after the injection a dynamic PET/MR imaging of the tumor sites including heart or large arterial blood pools will be conducted over 90 minutes.
Radiotracer for PET-imaging
Other Name: non-invasive imaging of tumor senescence
- Incidence and severity of adverse events (AEs) [ Time Frame: 7 days ]Incidence and severity of adverse events (AEs) (CTCAE V5.0) over 7 days Grade 1: no interruption; Grade 2: interrupt until Grade 0/1; Grade 3 and >3: interruption of study
- Number of patients exhibiting positive signals for senescent tumor cells in PET-imaging and/or tumor histopathology [ Time Frame: through study completion, an average of 6 month ]Positive [18F]FPyGal-PET-imaging of patient's tumor will be correlated with histopathology using senescence specific biomarkers against SABG (senescence-associated ß-galactosidase), p16, p21, and p53
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04536454
|Contact: Christian la Fougere, MD||+49-7071 firstname.lastname@example.org|
|Contact: Ulrich M Lauer, MD||+49-7071 email@example.com|
|Study Director:||Lars Zender, MD||University Hospital of Tübingen|