The aim of this study is to assess the ability of PET using [18F] fluorothymidine (FLT), an imaging biomarker, performed at week 10 of treatment can discriminate between pseudo progression and true progression as measured by MRI at 10 and 22 weeks,…
ID
Bron
Verkorte titel
Aandoening
Braintumor (GBM)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Comparison of FLT-PET response defined as a more than 25% reduction in
standardized uptake values (SUV) max (see section 7) at week 10 after start
temozolomide/radiotherapy to MRI response at 22 weeks between pseudo progression
and true progression.
Achtergrond van het onderzoek
The aim of this study is to assess the ability of PET using [18F] fluorothymidine (FLT), an
imaging biomarker, performed at week 10 of treatment can discriminate between pseudo
progression and true progression as measured by MRI at 10 and 22 weeks, in patients
with newly diagnosed GBM treated with concomitant and adjuvant chemoradiotherapy with
temozolomide.
Doel van het onderzoek
The aim of this study is to assess the ability of PET using [18F] fluorothymidine (FLT), an imaging biomarker, performed at week 10 of treatment can discriminate between pseudo progression and true progression as measured by MRI at 10 and 22 weeks, in patients
with newly diagnosed GBM treated with concomitant and adjuvant chemoradiotherapy with
temozolomide.
Onderzoeksopzet
To assess the ability of FLT-PET to discriminate between pseudo progression and true
progression as measured by MRI at 10 and 22 weeks in patients with newly diagnosed
GBM treated with concomitant and adjuvant chemoradiotherapy with temozolomide
baseline FLT-PET within 1 week before the initiation of treatment, and follow-up FLTPET
at 10 weeks after start of treatment and conventional MRI before, at 10 and at 22
weeks, will be assessed. For secondary endpoints OS at 6 and 12 months,
immunohistochemical staining for Ki-67 on tumor and MRI within 1 week before the
initiation of treatment, and follow-up MRI at 10 and 22 weeks will be performed.
Onderzoeksproduct en/of interventie
To assess the ability of FLT-PET to discriminate between pseudo progression and true
progression as measured by MRI at 10 and 22 weeks in patients with newly diagnosed
GBM treated with concomitant and adjuvant chemoradiotherapy with temozolomide.
Baseline FLT-PET within 1 week before the initiation of treatment, and follow-up FLTPET
at 10 weeks after start of treatment and conventional MRI before, at 10 and at 22
weeks, will be assessed. For secondary endpoints OS at 6 and 12 months,
immunohistochemical staining for Ki-67 on tumor and MRI within 1 week before the
initiation of treatment, and follow-up MRI at 10 and 22 weeks will be performed.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients with histologically confirmed newly diagnosed glioblastoma multiforme
(World Health Organization [WHO] grade IV astrocytoma) with indication and
eligibility for radiotherapy and concomitant TMZ followed by adjuvant TMZ. Patients
must have clinically and radiographically documented measurable disease.
Conventional MRI post surgery must be performed within 28 days prior to start of
combined treatment;
2. Absence of inability to undergo MRI or PET scanning;
3. Patients >18 years of age;
4. WHO performance status of 2 or less;
5. Absence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule;
those conditions should be discussed with the patient before registration in the trial;
6. Before patient registration/randomization, written informed consent must be given
according to ICH/GCP, and national/local regulations.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Patients with no histologically confirmed newly diagnosed glioblastoma multiforme
(World Health Organization [WHO] grade IV astrocytoma) or without indication and
eligibility for radiotherapy and concomitant TMZ followed by adjuvant TMZ. No conventional MRI post surgery;
2. Inability to undergo MRI or PET scanning;
3. Patients <18 years of age;
4. WHO performance status of 3;
5. Any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule;
those conditions should be discussed with the patient before registration in the trial;
6. No written informed consent.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3518 |
| NTR-old | NTR3680 |
| Ander register | METC UMCG : 200.83.45 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |