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)

NCT04536454 | Unknown Phase 1 DMC

• 1 other identifier: iFIT-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

It is of particular interest to find out whether it is possible to use the novel radiotracer \[18F\]FPyGal to be tested to detect areas after standard tumor therapy that contain resistant (therapy-resistant) tumor cells. This resistance phenomenon in tumor tissues, which may be visualized with the radiotracer \[18F\]FPyGal, is called tumor senescence.

Conditions

Cancer

Keywords

Senescence; [18F]FPyGal; PET / CT; PET / MRI

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events (AEs)

  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

  7 days

Secondary Outcomes (1)

• Number of patients exhibiting positive signals for senescent tumor cells in PET-imaging and/or tumor histopathology

  through study completion, an average of 6 month

Study Arms (1)

[18F]FPyGal

EXPERIMENTAL

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.

Drug: [18F]FPyGal

Interventions

[18F]FPyGal DRUG

Radiotracer for PET-imaging

Also known as: non-invasive imaging of tumor senescence

[18F]FPyGal

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients ≥ 18 years of age at the time of signing the informed consent
• Patients with locally advanced primary non-operable solid tumors (AEGs, rectum cancers, NSCLCs, NUT midline carcinomas (NMC))
• Eastern Cooperative Oncology Group Performance (ECOG) Status ≤ 2
• Adequate bone marrow, renal, and hepatic function defined by laboratory tests within 14 days prior to study treatment:
• Neutrophil count ≥ 1,500/mm3
• Platelet count ≥ 100,000/µl
• Bilirubin ≤ 1.5 x upper limit of normal (ULN)
• ALT (alanine transaminase) and AST (aspartate transaminase) ≤ 2.5 x ULN
• PT-INR (prothrombin time and international normalized ratio) /PTT (partial thromboplastin time)= ≤ 1.5 x ULN
• Creatine kinase ≤ 2.5 x ULN
• Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 ml/min
• Patients scheduled for neo-adjuvant (radio-) chemotherapy and subsequent tumor surgery (Groups a-c) or tumor biopsy (Group d)
• Understand and voluntarily sign an informed consent document prior to any study related assessments/ procedures.
• Able to adhere to the study visit schedule and other protocol requirements
• Consent to practice double-barrier contraception until end of the study (28 days after last \[18F\]FPyGal injection)

You may not qualify if:

• Any contraindication for MRI (impaired renal function and / or known hypersensitivity to gadolinium-containing contrast agent are not considered as contraindication, since then imaging will be performed without gadolinium contrast agent).
• Known hypersensitivity to \[18F\]FPyGal or its components or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
• Administration of any kind of PET tracer within a period corresponding to 8 half-lives of the representative radionuclide (e.g. for fluorine-18: 109.77 min, 8x109.77 min =14.7 h)
• Persistent toxicity (\>Grade 2) according to Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0, caused by previous cancer therapy, excluding alopecia
• Clinical signs of active infection (\> Grade 2 according to CTCAE version 5.0)
• History of HIV infection
• Immunocompromised patients
• Active or chronic viral hepatitis (HBV or HCV)
• History of autoimmune disease
• History of relevant CNS pathology or current relevant CNS (central nervous system) pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder) Epilepsy requiring pharmacologic treatment
• Therapeutic anticoagulation therapy
• Major surgery within 4 weeks of starting study treatment. Patients must have recovered from any effects of major surgery.
• Patients receiving any systemic chemotherapy or radio-therapy within 2 weeks prior to study treatment or a longer period depending on the defined characteristics of the agents used
• Heart failure NYHA (New York Heart Association) III/IV
• Severe obstructive or restrictive ventilation disorder

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital of Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Lars Zender, MD

  University Hospital of Tübingen

  STUDY DIRECTOR

Central Study Contacts

Christian la Fougere, MD

CONTACT

+49-7071 29-0; christian.lafougere@med.uni-tuebingen.de

Ulrich M Lauer, MD

CONTACT

+49-7071 29-0; ulrich.lauer@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: September 2, 2020
• Study Start: April 28, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: May 11, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)