18F-FET PET in Childhood Brain Tumours
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| ClinicalTrials.gov Identifier: NCT03216148 |
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Recruitment Status : Unknown
Verified July 2017 by PD Dr. Pablo Hernaiz Driever, Charite University, Berlin, Germany.
Recruitment status was: Recruiting
First Posted : July 13, 2017
Last Update Posted : July 21, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Brain Neoplasm | Diagnostic Test: FET-PET | Phase 2 |
2.1 Primary objective The main objective is to evaluate the relative benefit of FET PET in comparison to the MRI in differentiating biologically active tumour tissue from therapy-related changes in paediatric brain tumours after first line therapy (Δ specificityFET PET to specificityMRT) 2.2 Secondary Objectives To assess sensitivity of FET PET in comparison with the sensitivity of MRI (Δ sensitivityFET PET to sensitivityMRT) To assess the positive and negative predictive values (PPV, NPV) of FET PET in comparison with the PPV and NPV of MRI (Δ PPVFET PET to PPVMRT, Δ NPVFET PET to NPVMRT) To evaluate specificity, sensitivity, PPV, and NPV by SUVratio analyses of FET PET data To evaluate the potential of FET PET for non-invasive tumour grading (WHO I/II vs. III/IV) by kinetic studies when histology is available To assess adverse events and toxicity profile
2.3 Endpoints (Standard of truth1) 2.3.1 Primary Endpoint The primary endpoint is an event free survival of the follow-up period of 24 (12) months after first line therapy (confirmed by clinical and neuroradiological assessment) or the confirmed diagnosis of progression or recurrence of brain tumour tissue (confirmed by histology or clinical and neuroradiological assessment).
The follow-up period for patients with a low risk of tumour recurrence after first line therapy, i.e. astrocytoma WHO grade I-II, oligodendroglioma WHO grade I-II, germ cell tumour, choroid plexus tumour, craniopharyngioma will be 24 months.
The follow-up period for patients with a high risk of tumour recurrence after first line therapy, i.e. astrocytoma WHO grade III-IV, oligodendroglioma WHO grade III-IV, medulloblastoma, supratentorial PNET, AT/RT and other high-grade tumour lesions will be 12 months.
2.3.2 Secondary Endpoints To assess the secondary objectives of the FET PET 2010 study, the investigators will determine event free survival of the follow-up period of 24 (12) months after first line therapy (confirmed by clinical and neuroradiological assessment) or the confirmed diagnosis of progression or recurrence of brain tumour tissue (confirmed by histology or clinical and neuroradiological assessment).
Histopathological characteristics of recurrent tumours (WHO grade I-IV) Safety and Toxicity (evolution according to CTCEA v3.0 criteria): the NCI Common Terminology Criteria for Adverse Events v3.0 is a descriptive terminology, that is used for Adverse Event (AE) reporting. A grading scale is provided for each AE term. Attached is a selection of categories, which are required to assess safety and toxicity of FET PET examinations.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 160 participants |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | All pediatric patients with brain Tumor receive a FET-PET Investigation in Addition to conventional MRI at the end of the first-line therapy. In case of Progression or Relapse patients may receive a second FET-PET Investigation in Addition to Routine surveillance MRI. |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | A Prospective, Multicentre Trial on the Value of 18F-FET PET in the Post-therapeutic Evaluation of Childhood Brain Tumours |
| Study Start Date : | July 2015 |
| Estimated Primary Completion Date : | July 2018 |
| Estimated Study Completion Date : | July 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: FET-PET
All participating patients will receive a FET PET-scan with intravenous O-(2-[18F]Fluoroethyl)-L-Tyrosine parallel to the routine MRI at the end of the first line therapy (restaging) according to the HIT-protocol Second FET PET: In case of suspected tumour recurrence or progression within the follow-up period of 24 (12) months, the participating patient will receive a second FET PET-scan (parallel to an MRI)
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Diagnostic Test: FET-PET
All participating patients will receive a FET PET-scan parallel to the routine MRI at the end of the first line therapy (restaging) according to the HIT-protocol Second FET PET: In case of suspected tumour recurrence or progression within the follow-up period of 24 (12) months, the participating patient will receive a second FET PET-scan (parallel to an MRI)
Other Name: O-(2-[18F]Fluoroethyl)-L-Tyrosine |
- Differentiating biologically active Tumor tissue from therapy related changes by using MRI (Magnetic Resonance Imaging) and FET PET [ Time Frame: 3 years ]The main objective is to evaluate the relative benefit of FET PET in comparison to the MRI in differentiating residual biologically active tumour tissue from therapy related changes in paediatric brain tumours after first line therapy (Δ specificityFET PET to specificityMRT)
- Sensitivity of FET-PET when differentiating biologically active Tumor tissue from therapy-related changes by using MRI (Magnetic Resonance Imaging) and FET PET [ Time Frame: 3 years ]To assess sensitivity of FET PET in comparison with the sensitivity of MRI (Δ sensitivityFET PET to sensitivityMRT)
- Assessment of the predictive value of FET-PET when differentiating biologically active Tumor tissue from therapy-related changes by using MRI (Magnetic Resonance Imaging) and FET PET [ Time Frame: 4 years ](PPV, NPV) of FET PET in comparison with the PPV and NPV of MRI (Δ NPVFET PET to NPVMRT)
- Assessment of Tumor grading by FET-PET when differentiating biologically active Tumor tissue from therapy-related changes by using MRI (Magnetic Resonance Imaging) and FET PET [ Time Frame: 4 years ]SUVratio analyses of FET PET data to allow for Analysis of Tumor grading when histological results are available
- Safety data on FET-PET in children with brain tumors [ Time Frame: 3 years ]To assess adverse events and toxicity Profile using Common Terminology Criteria for Adverse Events, CTCAE v4.03
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| Ages Eligible for Study: | 1 Year to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Written informed consent (given by the parents as legal representatives of the patients and given by the patients)
- Completion of the first line therapy according to the current HIT-protocols (Current and subsequent paediatric primary brain tumour treatment studies approved by GPOH)
- Fully evaluable MRI at the end of first line therapy as confirmed by the reference centre of neuroradiology (Prof. Dr. M. Warmuth-Metz, Würzburg)
- Histology of primary brain tumour confirmed by local and reference centre of Neuropathology (Prof. Dr. T. Pietsch) except for patients where tumour diagnosis is confirmed by the reference centre of neuroradiology, i.e. NF-1 and confirmed LGG or patient with diffuse intrinsic pontine glioma
- Laboratory requirements prior to enrolment: Serum creatinine: within normal limits; AST, ALT: not more than 10 x above normal limits
- Age at inclusion: 1 year to 17 years
- Children below the age of 12 years are included as 2 of 3 paediatric patients with a brain tumour are younger than 12 years. Furthermore, young age is a known negative risk factor for different histological entities. Thus, this group is the most likely to benefit from the results of this study
- In all patients with reproductive potential, a pregnancy must be excluded by a pregnancy test before FET PET investigation
- Highly effective contraception in women with reproductive potential (defined as pearl index < 1) during study participation and follow up time
- No participation in other clinical trials according to AMG with the same clinical indication over the course of the FET PET 2010 study
Exclusion Criteria:
- Presence of solid non-CNS tumours or leukaemia
- MRI at completion of first line therapy that does not meet standard quality criteria for evaluation as defined by the reference centre for neuroradiology of the HITNetzwerk (Würzburg, Prof. Warmuth-Metz);
- Known allergic reactions or drug intolerance to contrast agents
- Patients according to § 88 StrhlSchV
- Pregnancy or breast-feeding
- Women (adolescents) of childbearing potential without highly effective contraception (PEARL-Index < 1%), for example ParaGard IntraUterineDevice (IUD), Mirena IUD, Implants, Depo Provera Injections;
- Persons who are detained officially or legally to an official institute
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): NCT03216148
| Contact: Uwe Behrens, PhD | uwe.behrens@charite.de | ||
| Contact: Ramona Stöckl | ramona.stoeckl@charite.de |
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| Principal Investigator: | Pablo Hernáiz Driever, MD | Charite University, Berlin, Germany | |
| Study Chair: | Michail Plotkin, MD | Vivantes Klinikum |
| Responsible Party: | PD Dr. Pablo Hernaiz Driever, Principal Investigator, Charite University, Berlin, Germany |
| ClinicalTrials.gov Identifier: | NCT03216148 |
| Other Study ID Numbers: |
FET PET 2010 2008-005786-60 ( EudraCT Number ) |
| First Posted: | July 13, 2017 Key Record Dates |
| Last Update Posted: | July 21, 2017 |
| Last Verified: | July 2017 |
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FET PET |
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Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site |
Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases |