CancerPhase 1/2SenPETNCT04536454
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)
A Phase 1/2 study testing [18F]FPyGal in people with Cancer, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cancer
- What is being tested?
- [18F]FPyGal
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 28 Apr 2021to Jun 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
- Females of childbearing potential (FCBP) must agree
- to use two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including dose interruptions), and for at least 28 days after end of study treatment and must agree to pregnancy testing during this timeframe
- to abstain from breastfeeding during study participation and 7 days after end of study drug administration.
- Males must agree
- to use a latex condom during any sexual contact with FCBP while participating in the study and for at least 28 days after end of study treatment, even if he has undergone a successful vasectomy
- to refrain from donating semen or sperm while participating in the study and for at least 28 days after end of study treatment.
Who cannot join
- 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
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- 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
- Known history of GI-perforation
- Patients not able to declare meaningful informed consent on their own
- Women during pregnancy and lactation; female patients of childbearing potential or male patients with female partners of childbearing potential not willing to practice effective contraception by using a double-barrier method from Day 0 until 28 days post-dose.
- Male patients planning to donate sperm while participating in the study and for at least 28 days after end of study treatment.
- Participation in other clinical trials or observation period of competing trials
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Tübingen
Tübingen, Baden-Wurttemberg, 72076
Christian la Fougere, MD, +49 7071 29-86553, christian.lafougere@med.uni-tuebingen
Lars Zender, MD, +49 7071 29-83675, lars.zender@med.uni-tuebingen.de
About this study
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
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.
Read the detailed description
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.
- Conditions
- Cancer
- Being tested
- [18F]FPyGal
- Keywords
- Senescence, [18F]FPyGal, PET / CT, PET / MRI
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FPyGalDrug
Also called non-invasive imaging of tumor senescence
Radiotracer for PET-imaging
| Study group | Role | What they receive |
|---|---|---|
| [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. Receives: Drug: [18F]FPyGal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (1)
Number of patients exhibiting positive signals for senescent tumor cells in PET-imaging and/or tumor histopathology
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
Measured: through study completion, an average of 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start28 Apr 2021
- Primary completionJun 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars Zender, MD, Study director, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536454
- Sponsor's protocol ID
- iFIT-01
- Acronym
- SenPET
- Status last verified
- Aug 2020
- First submitted
- 20 Aug 2020
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04536454
- Acronym / sponsor ID
- SenPET / iFIT-01
- Conditions
- Cancer
- Keywords
- Senescence, [18F]FPyGal, PET / CT, PET / MRI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]FPyGal | Experimental | Drug: [18F]FPyGalCancer 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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:
- Patients scheduled for neo-adjuvant (radio-) chemotherapy and subsequent tumor surgery (Groups a-c) or tumor biopsy (Group d)
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]FPyGalAlso: non-invasive imaging of tumor senescenceRadiotracer for PET-imaging | Drug | [18F]FPyGal |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Zender, MD study director
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [18F]FPyGal in people with Cancer, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian la Fougere, MD (+49-7071 29-0, christian.lafougere@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.