225 Participants Needed

Mapping Techniques for Recurrent Brain Cancer

(RECMAP Trial)

Recruiting at 7 trial locations
AV
JG
Overseen ByJasper Gerritsen, MD PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Erasmus Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to safely remove recurrent glioblastoma, a type of brain cancer, when it is near critical brain areas. It compares three methods: surgery with awake mapping (testing brain function while awake), asleep mapping, and no mapping. The goal is to determine which method reduces surgery-related issues and leaves less tumor behind. Individuals with recurrent glioblastoma, with tumors near areas controlling movement or speech, might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in glioblastoma treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both awake and asleep mapping techniques during brain surgery are generally safe for patients. Studies indicate that the risk of temporary or permanent nerve issues after surgery is similar for both methods, meaning safety is comparable whether patients are awake or asleep during mapping.

For asleep mapping, research suggests a low rate of permanent nerve issues, particularly with less severe brain tumors. This technique helps doctors locate and avoid important brain areas during surgery, potentially improving outcomes.

Awake mapping also aids doctors in identifying and protecting critical brain areas, such as those controlling speech and movement, while the patient is awake. This can reduce the risk of affecting these functions.

Overall, both mapping methods are well-tolerated and enhance surgical safety by protecting important brain functions.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative techniques for glioblastoma surgery. Unlike traditional surgery, which typically doesn't involve mapping, this trial investigates intraoperative mapping methods—both asleep and awake—to potentially enhance tumor removal precision. Asleep mapping focuses on motor mapping while the patient is under anesthesia, and awake mapping involves motor or language mapping with the patient conscious, which might allow for better protection of critical brain functions. By comparing these approaches to standard surgery without mapping, researchers hope to identify strategies that may improve outcomes and preserve patients' quality of life.

What evidence suggests that this trial's mapping techniques could be effective for recurrent glioblastoma?

This trial will compare different intraoperative mapping techniques for tumor resection. Research has shown that both awake and asleep mapping techniques can help surgeons safely remove brain tumors like glioblastoma. These techniques involve monitoring brain functions such as movement and speech during surgery to avoid damaging critical areas. Studies indicate that both awake and asleep mapping enable surgeons to remove more of the tumor while preserving patients' abilities. Specifically, awake mapping reduces language problems, while asleep mapping is associated with fewer movement issues. Although these methods are effective for newly diagnosed tumors, their benefits for recurring glioblastoma remain under investigation.23567

Who Is on the Research Team?

JG

Jasper Gerritsen, MD PhD

Principal Investigator

Erasmus Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

My tumor is located in a critical area of the brain.
My neurosurgeon says my tumor can be surgically removed.
I have signed the consent form.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo tumor resection with either awake mapping, asleep mapping, or no mapping

Within 72 hours postoperatively

Follow-up

Participants are monitored for safety and effectiveness after surgery, with evaluations at 6 weeks, 3 months, and 6 months postoperatively

6 months
3 visits (in-person)

Long-term follow-up

Participants are monitored for overall survival and progression-free survival

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Asleep Mapping
  • Awake Mapping
  • Resection without Mapping

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: No mappingExperimental Treatment1 Intervention
Group II: Awake mappingExperimental Treatment1 Intervention
Group III: Asleep mappingExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Erasmus Medical Center

Lead Sponsor

Trials
742
Recruited
2,156,000+

Universitaire Ziekenhuizen KU Leuven

Collaborator

Trials
1,048
Recruited
1,658,000+

Haaglanden Medical Centre

Collaborator

Trials
18
Recruited
11,200+

University Hospital Heidelberg

Collaborator

Trials
258
Recruited
278,000+

Technical University of Munich

Collaborator

Trials
395
Recruited
813,000+

Insel Gruppe AG, University Hospital Bern

Collaborator

Trials
831
Recruited
2,353,000+

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

Citations

Neurological outcomes following awake and asleep ...

The rates of transient and permanent postoperative neurologic deficits among awake versus asleep cortical mapping groups are similar.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39560794/

Comparative efficacy of awake and asleep motor mapping ...

This meta-analysis suggests that AC and GA are comparable approaches to maximize extent of resection and achieve safe resection in eloquent glioma surgery.

Asleep triple-modality motor mapping for perirolandic gliomas

Asleep triple motor mapping results in a low rate of permanent deficits, especially for low-grade gliomas.

Awake vs. asleep motor mapping for glioma resection

Intraoperative stimulation (IS) mapping allows real-time and accurate identification of the cortical and subcortical eloquent areas as well as tumor-related ...

a systematic review and meta-analysis - eClinicalMedicine

This study aims to evaluate the efficacy of preoperative and intraoperative mapping techniques on resection outcomes and post-operative deficits. Methods.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35051704/

Neurological outcomes following awake and asleep ...

Review of the current evidence suggests that the rates of transient and permanent postoperative neurologic deficits among awake versus asleep cortical mapping ...

Clinical Pearls and Methods for Intraoperative Motor Mapping

The use of motor mapping improves resection and outcomes in patients harboring tumors involving motor areas and pathways, and should be considered the gold ...