Clinical trial · Interventional
Image-Based Quantitative Assessment of Acute Radiation-Induced Changes in Glioma
NCT03168919CI-TRIAL-00040932terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI is leaving institution
Summary
Brief summary (as posted)
The overall goal of this study is to determine if quantitative imaging techniques can be used to detect dynamic changes of morphology and different physiologic properties of the tumor during and after completion of radiation treatment and to predict site and time of radiation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fractionated Radiation | Radiation | — | UNRESOLVED |
| MRI | Device | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemoradiation with MRI assessment
- description
- This study has only one arm. The eligible subjects will receive standard of care fractionated radiation therapy along with concomitant temozolomide, which will NOT be changed based on the MRI scans obtained as a part of this study. There is no control or sham group.
- interventionNames
- Radiation: Fractionated Radiation
- Drug: Temozolomide
- Device: MRI
Primary outcomes (1)
- measure
- Number of Participants With the Changes of the Chemical Environment of the Tumor
- timeFrame
- From Baseline to 6 weeks.
- description
- Multiple MRI techniques will be used to assess chemical environment (Cho/NAA) of the tumor during the course of fractionated radiation treatment.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed glioma, based on pathology confirmation; 2. At least 8 cm3 of residual enhancing tumor after surgery or significant visible tumor (As seen on immediate postoperative scan); 3. Scheduled to receive standard fractionated RT with concomitant temozolomide therapy; 4. Karnofsky Performance Score \> 60. Exclusion Criteria: 1. Scheduled to receive investigational chemotherapy, immunotherapy, or any other investigational agents; 2. Placement of GLIADEL® wafer in the resection cavity; 3. Significant amount of hemorrhage within the resection cavity (seen on immediate post-operative scan); 4. A large peritumoral infraction related to surgery (identified by new confluent diffusion restriction); 5. Not suitable to undergo MRI or use the MRI contrast agent (GFR\<30 mL/min/1.73 m2); or the patient has known anaphylactic reaction to gadolinium based contrast agents. 6. Presence of serious systemic illness, including: uncontrolled infection, uncontrolled malignancy, significant renal disease, or psychiatric/social situations, which might impact the survival endpoint of the study or limit compliance with study requirements.
References
Publications (0)
Data not yet available
No reference posted for this study.