---
title: Image Guided Therapy in the Treatment of Gliomas
nct_id: NCT01263821
overall_status: TERMINATED
phase: NA
sponsor: NYU Langone Health
study_type: INTERVENTIONAL
primary_condition: Glioma
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01263821.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01263821"
ct_last_update_post_date: 2017-08-04
last_seen_at: "2026-05-12T06:39:16.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Image Guided Therapy in the Treatment of Gliomas

**Official Title:** Image Guided Adaptive Multi-modality Therapy in the Treatment of Gliomas

**NCT ID:** [NCT01263821](https://clinicaltrials.gov/study/NCT01263821)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Lack of enrollment
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 15
- **Lead Sponsor:** NYU Langone Health
- **Conditions:** Glioma
- **Start Date:** 2009-08
- **Completion Date:** 2014-04
- **CT.gov Last Update:** 2017-08-04

## Brief Summary

RATIONALE: New imaging techniques using magnetic resonance imaging give better tumor definition, thus may lead to better tumor targeting and avoid damaging critical parts of normal brain.

PURPOSE: This phase I/II trial is studying how well image-guided therapy works in treating patients with newly diagnosed intracranial glioma.

## Detailed Description

PRIMARY OBJECTIVES:

I. To correlate the imaging findings with pathological grade following surgery in patients with newly diagnosed intra-cranial gliomas.

SECONDARY OBJECTIVES:

I. To determine the feasibility of defining the optimal target volume for radiation therapy using MR spectroscopy, diffusion, perfusion and functional imaging. II. To monitor therapeutic responses following treatment using MR spectroscopy, diffusion imaging and perfusion study.

III. To monitor changes in neurocognitive functioning following image guided therapy.

OUTLINE: Patients undergo magnetic resonance spectroscopic imaging, functional magnetic resonance imaging (MRI), diffusion-weighted MRI, and perfusion-weighted MRI. Patients then undergo maximum surgical resection followed by intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks. After completion of study treatment, patients are followed up every 3 months for the first year then every 6 months for another year.

## Eligibility

- **Minimum age:** 7 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Histologically confirmed, newly diagnosed intracranial glioma
* A diagnostic contrast enhanced CT/MRI demonstrating the lesion prior to registration
* Karnofsky performance status \>= 60
* Ability to undergo MR imaging with the use of Gadolinium dye
* Patient must sign a study specific informed consent form; if the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the patient's legal representative

Exclusion Criteria:

* Inability to obtain histological proof of glioma
* Allergy to Gadolinium contrast
* Any condition including metallic implants or cardiac pace makers that make the candidate ineligible for MR imaging
* Any medical condition including renal or cardiac insufficiency that make the candidate a high risk for gadolinium contrast administration
* Karnofsky performance status of =\< 50
* Prior history of radiation therapy to the brain
* Pregnancy
```

## Arms

- **Arm I** (EXPERIMENTAL) — Patients undergo magnetic resonance spectroscopic imaging, functional magnetic resonance imaging (MRI), diffusion-weighted MRI, and perfusion-weighted MRI. Patients then undergo maximum surgical resection followed by intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks.

## Interventions

- **Diffusion-weighted magnetic resonance imaging** (PROCEDURE) — Undergo diffusion-weighted MRI
- **Perfusion-weighted magnetic resonance imaging** (PROCEDURE) — Undergo perfusion-weighted magnetic resonance imaging
- **Functional magnetic resonance imaging** (PROCEDURE) — Undergo functional MRI
- **Magnetic resonance spectroscopic imaging** (PROCEDURE) — Undergo MR spectroscopic imaging
- **Therapeutic conventional surgery** (PROCEDURE) — Undergo maximal surgical resection
- **Quality-of-life assessment** (PROCEDURE) — Ancillary studies
- **Radiation therapy treatment planning/simulation** (PROCEDURE) — Undergo IMRT planning
- **Intensity-modulated radiation therapy** (PROCEDURE) — Undergo intensity-modulated radiation therapy
- **Questionnaire administration** (OTHER) — Ancillary studies

## Primary Outcomes

- **Feasibility of identifying low grade and high grade tumor location with imaging techniques that include MRSI,perfusion MRI, and DTI** _(time frame: Twice a year, after enrollment of first 25 patients, and at study completion)_

## Secondary Outcomes

- **Incorporate imaging techniques of MRSI, perfusion MRI and DTI into the radiotherapy treatment planning system for target delineation** _(time frame: Twice a year, after enrollment of first 25 patients, and at study completion)_
- **Clinical efficacy of this biological image-guided treatment in gliomas** _(time frame: Twice a year, after enrollment of first 25 patients, and at study completion)_

## Locations (1)

- NYU Cancer Institute, New York, New York, United States

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.nyu cancer institute|new york|new york|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01263821*  
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