Markers of Aggressive Local Therapy In Newly diagnosed Glioblastomas

Magnetic resonance imaging to characterise invasive phenotypes in cerebral gliomas: an observational prospective cohort study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN62033854

Enrollment

145

Registered

2011-03-04

Start date

2010-03-01

Completion date

Unknown

Last updated

2019-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastomas Cancer Malignant neoplasm of brain

Interventions

This study will include three patient cohorts: 1. Markers of Aggressive Local Therapies in Newly diagnosed Glioblastomas (MALTING): This project will involve recruitin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Imaging appearances of a high grade glioma 2. Likely to be suitable for radiotherapy (60 Gy) with concomitant and adjuvant temozolomide 3. World Health Organization (WHO) performance status (PS) grade 0 or 2 4. Aged 18 - 75 years, either sex 5. Resection or biopsy (although only those suitable for maximal resection will be considered for the MALTING Trial) Patients for the MALTING Trial will be felt by their consultant neurosurgeon to be suitable for 5-aminolevulinic acid (5-ALA) fluorescence-guided resection with insertion of carmustine wafers.

Exclusion criteria

Exclusion criteria: 1. Unsuitable for a contrast-enhanced MRI (MR unsafe metallic implants, claustrophobia, allergy to gadolinium contrast agent or severe renal impairment) 2. Pregnant 3. Allergic to aminolevulinic acid 4. Suffering from porphyria. Care will be taken if the patient is taking other photosensitising drugs.

Design outcomes

Primary

Measure	Time frame
Pattern of contrast enhancement at first recurrence. This will be assessed by co-registering anatomical MR's at recurrence with pre-RT and highlighting areas of new contrast enhancement. Invasive GBM's will be defined as radiological evidence of > 80% of the recurrent tumour occurring outside the radiotherapy 95% isodose. For the MALTING study, the percentage of patients surviving 2 years will be the main outcome measure.	—

Measure

Time frame

Pattern of contrast enhancement at first recurrence. This will be assessed by co-registering anatomical MR's at recurrence with pre-RT and highlighting areas of new contrast enhancement. Invasive GBM's will be defined as radiological evidence of > 80% of the recurrent tumour occurring outside the radiotherapy 95% isodose. For the MALTING study, the percentage of patients surviving 2 years will be the main outcome measure.

—

Secondary

Measure	Time frame
1. Overall survival 2. Time to radiological progression: Radiological progression is defined as per MacDonald criteria i.e. a 25% or greater increase in the size of the tumour (as defined by the product of two perpendiculars of the enhancing component) or the appearances of new contrast-enhancing lesions. 3. Time to clinical progression: This will be defined as the presence of any of the following: 3.1. Neurological deterioration with or without the need for increased steroid use 3.2. Increased steroid requirements for more than 2 weeks including for increasing neurological deficit and/or features of increased intracranial pressure suggestive of tumour progression when other causes have been excluded. 3.3. Deterioration of ? 1 point in WHO performance status, compared with previous assessment 3.4. Increased symptoms of raised intracranial pressure (headache, nausea/vomiting etc.) 4. The extent to which conventionally planned RT volumes encompassed the abnormalities identified using advanced imaging 5. For the MALTING study, patients outcome will be compared to predicted outcome from the prognostic model proposed by Gorlia et al (Lancet Oncology, 2008). This uses a normogram that involves MGMT promoter methylation status, age, performance status, extent of resection, and Mini-Mental State Examination (MMSE) to predict outcome. Using a modified Sliding Dichotomy design, the outcome for each patient is compared to their predicted outcome.	—

Measure

Time frame

1. Overall survival 2. Time to radiological progression: Radiological progression is defined as per MacDonald criteria i.e. a 25% or greater increase in the size of the tumour (as defined by the product of two perpendiculars of the enhancing component) or the appearances of new contrast-enhancing lesions. 3. Time to clinical progression: This will be defined as the presence of any of the following: 3.1. Neurological deterioration with or without the need for increased steroid use 3.2. Increased steroid requirements for more than 2 weeks including for increasing neurological deficit and/or features of increased intracranial pressure suggestive of tumour progression when other causes have been excluded. 3.3. Deterioration of ? 1 point in WHO performance status, compared with previous assessment 3.4. Increased symptoms of raised intracranial pressure (headache, nausea/vomiting etc.) 4. The extent to which conventionally planned RT volumes encompassed the abnormalities identified using advanced imaging 5. For the MALTING study, patients outcome will be compared to predicted outcome from the prognostic model proposed by Gorlia et al (Lancet Oncology, 2008). This uses a normogram that involves MGMT promoter methylation status, age, performance status, extent of resection, and Mini-Mental State Examination (MMSE) to predict outcome. Using a modified Sliding Dichotomy design, the outcome for each patient is compared to their predicted outcome.

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026