Non-seminomatous Germ Cell TumorsPhase 2TERMATEPNCT02317393
Contribution of the Imaging to the Expression of intégrines αvβ3 for the Characterization of Residual Masses of Non-seminoma Tumors at the End of Chemotherapy
A Phase 2 study testing K5-RGD PET and FDG in people with Non-seminomatous Germ Cell Tumors and Metastasis, run by Centre Francois Baclesse at 5 sites in France.
Trial summary
The purpose of this study is to evaluate the contribution of the imaging to the expression of intégrines αvβ3 for the characterization of the residual masses of non-seminoma tumors at the end of chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-seminomatous Germ Cell Tumors, Metastasis
- What is being tested?
- K5-RGD PET and FDG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 5 sitesFrance
- Study dates
- Dec 2014to Mar 2020
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman aged 18 years or more
- Patients with one or several ganglionic or visceral residual masses (> to 1 cm) after chemotherapy for metastatic non-seminoma testicular tumor, and for which or which a surgery is planned;
- Affiliate to a social security system;
- Signed written Informed consent
Who cannot join
- Patient deprived of liberty as a result of a justice or administrative decision
- Any medical or psychological condition which could compromise the capacity of the patient to participate in the study;
- Previous or concomitant other cancer in 5 years except basal cell carcinomas
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU
Caen, 14000
Centre François Baclesse
Caen, 14076
Centre Henri Becquerel
Rouen
CHU Rouen
Rouen
Institut Claudius Regaud
Toulouse
About this study
Official title: A Prospective,Multicenter, Phase II Study to Evaluate the Contribution of the Imaging TEP to the Expression of intégrines αvβ3 for the Characterization of the Residual Masses of Non-seminoma Tumors at the End of Chemotherapy
The purpose of this study is to evaluate the contribution of the imaging to the expression of intégrines αvβ3 for the characterization of the residual masses of non-seminoma tumors at the end of chemotherapy.
The investigators hope that the results of this first stage of the clinical trial come to consolidate the preclinical results obtained by the investigators team to characterizing the interest and the strong contribution of the use of a tracer resting on the expression of αvβ3 integrine for the diagnosis of simple necrosed mass at the end of the treatment of a non-seminoma tumor, so allowing to defer a surgery to about 40 % of the patients.
- Conditions
- Non-seminomatous Germ Cell Tumors, Metastasis
- Being tested
- K5-RGD PET, FDG
- Keywords
- Nuclear medicine, Positron emission tomography, avb3 integrin expression
- Medical subject headings
- Nonseminomatous germ cell tumor, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K5-RGD PETOther
Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy
FDGOther
Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| K5-RGD PET + FDG | Other | Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy, with a maximal delay from end of chemotherapy of 2 months. Delay between FDG and 18F-K5-RGD PET scans will not exceed 2 weeks. Receives: Other: K5-RGD PET; Other: FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of teratoma
Efficacity to differentiate mature teratoma and necroses within the residual masses of germinal non-seminoma tumors.
Measured: up to 6 weeks
Secondary outcomes (1)
Metabolic profile
Number of patients having at least a tumor detected by TEP K5-RGD requiring a surgery, divided by the number of patients having actually at least a tumor (by anatomopathologie) requiring a chirurgie
Measured: up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-seminomatous Germ Cell TumorsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas AIDE, Dr, Principal investigator, Centre François Baclesse, CAEN, FranceArnaud DOERFLER, Dr, Principal investigator, CHU Côte de Nacre, CAEN, FrancePierre VERA, Dr, Principal investigator, Centre Henri Becquerel, ROUEN, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317393
- Sponsor's protocol ID
- TERMATEP
- Acronym
- TERMATEP
- Status last verified
- Feb 2020
- First submitted
- 25 Aug 2014
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective,Multicenter, Phase II Study to Evaluate the Contribution of the Imaging TEP to the Expression of intégrines αvβ3 for the Characterization of the Residual Masses of Non-seminoma Tumors at the End of Chemotherapy
- ClinicalTrials.gov ID
- NCT02317393
- Acronym / sponsor ID
- TERMATEP / TERMATEP
- Conditions
- Non-seminomatous Germ Cell Tumors, Metastasis
- Keywords
- Nuclear medicine, Positron emission tomography, avb3 integrin expression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 16 Dec 2014 (estimated)
- 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.
The purpose of this study is to evaluate the contribution of the imaging to the expression of intégrines αvβ3 for the characterization of the residual masses of non-seminoma tumors at the end of chemotherapy.
The investigators hope that the results of this first stage of the clinical trial come to consolidate the preclinical results obtained by the investigators team to characterizing the interest and the strong contribution of the use of a tracer resting on the expression of αvβ3 integrine for the diagnosis of simple necrosed mass at the end of the treatment of a non-seminoma tumor, so allowing to defer a surgery to about 40 % of the patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| K5-RGD PET + FDG | Other | Other: K5-RGD PET, Other: FDGBoth PET examinations will be performed within 4-6 weeks after the end of chemotherapy, with a maximal delay from end of chemotherapy of 2 months. Delay between FDG and 18F-K5-RGD PET scans will not exceed 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Man or woman aged 18 years or more
- Patients with one or several ganglionic or visceral residual masses (> to 1 cm) after chemotherapy for metastatic non-seminoma testicular tumor, and for which or which a surgery is planned;
- Affiliate to a social security system;
- Signed written Informed consent
Key exclusion criteria (3 listed)
- Patient deprived of liberty as a result of a justice or administrative decision
- Any medical or psychological condition which could compromise the capacity of the patient to participate in the study;
- Previous or concomitant other cancer in 5 years except basal cell carcinomas
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 |
|---|---|---|
| K5-RGD PETBoth PET examinations will be performed within 4-6 weeks after the end of chemotherapy | Other | K5-RGD PET + FDG |
| FDGBoth PET examinations will be performed within 4-6 weeks after the end of chemotherapy | Other | K5-RGD PET + FDG |
Primary outcome
Proportion of teratoma
Time frame: up to 6 weeks
Efficacity to differentiate mature teratoma and necroses within the residual masses of germinal non-seminoma tumors.
1 secondary outcome
Metabolic profile
Time frame: up to 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
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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.
Nicolas AIDE, Dr principal investigator
Centre François Baclesse, CAEN, France
Arnaud DOERFLER, Dr principal investigator
CHU Côte de Nacre, CAEN, France
Pierre VERA, Dr principal investigator
Centre Henri Becquerel, ROUEN, France
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing K5-RGD PET and FDG in people with Non-seminomatous Germ Cell Tumors and Metastasis, run by Centre Francois Baclesse at 5 sites in France.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of teratoma (time frame: up to 6 weeks). 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 9 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.