MRI and Blood Biomarkers for Brain Cancer

CC
Overseen ByCaroline Chung
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer 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 examines how repeated MRI scans and blood tests can predict changes in thinking and memory following brain radiation, a type of cancer treatment. Researchers aim to determine if these tests can track patient responses to treatment and allow for adjustments if necessary. The trial is suitable for individuals scheduled to undergo brain radiation for at least five weeks and who can tolerate MRIs with contrast. Participants must also understand and complete cognitive tests in English and have no history of serious mental health issues or neurological disorders like dementia. As a Phase 2 trial, this study measures the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to important research.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot participate if you are on concurrent chemotherapy.

What prior data suggests that this protocol is safe for evaluating brain radiation effects?

Research has shown that brain radiation is usually well-tolerated, with some patients experiencing mild to moderate side effects. In one study involving patients with cancer spread to the brain, only about 3.2% experienced severe side effects. Another study found that brain radiation did not cause serious issues like brain bleeding or death. Additionally, more than 40% of patients with cancer spread to the brain demonstrated improvements in their thinking abilities after treatment.

Overall, while some side effects may occur, brain radiation is considered safe for most people. Those considering participation in trials should discuss potential risks and benefits with their healthcare providers.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to predict neurocognitive decline after brain radiation using MRI and blood biomarkers. Unlike standard approaches that wait for symptoms to appear, this method uses advanced imaging and blood tests to identify changes early on. This could lead to more personalized treatment plans, potentially improving patient outcomes by addressing issues before they worsen.

What evidence suggests that this method is effective for monitoring brain radiation effects?

Research has shown that brain radiation can be beneficial in certain situations, particularly for patients whose cancer has spread to the brain. While it might not significantly extend overall life expectancy, it has been linked to benefits such as reducing pain in more than half of the patients who survived at least three months after treatment. Additionally, when combined with the chemotherapy pill temozolomide, radiation therapy has improved survival rates in patients with glioma, a type of brain cancer. This suggests that brain radiation might help manage symptoms and potentially improve outcomes when used with other treatments. However, results can vary for each individual, so discussing expectations with a healthcare provider is important.678910

Who Is on the Research Team?

CC

Caroline Chung

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients must be planned for fractionated radiotherapy that will be delivered over at least 5 weeks and that will expose the brain to radiation
Patients must have Karnofsky performance status (KPS) >= 80
Patients must be able to obtain an MRI scan with gadolinium contrast
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo multiparametric MRI with and without contrast and blood sample collection during radiotherapy

6 weeks
Weekly visits for MRI and blood collection

Follow-up

Participants are monitored for neurocognitive changes with MRI and blood biomarkers post-radiotherapy

24 months
Visits at 1, 3, 6, 12, and 24 months post-radiotherapy

What Are the Treatments Tested in This Trial?

Interventions

  • Brain Radiation

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Observational (MRI, questionnaire, blood collection)Experimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Results - Radiation Therapy for Brain Metastases - NCBI - NIH

Overall survival (HR 2.00; CI 0.78 to 5.17; 1 RCT), progression-free survival (HR 3.10; CI 0.74 to 12.93; 1 RCT) and death due to brain metastases (RR 3.00; CI ...

Patient Reported Outcomes Following Palliative Whole ...

More than 50% of patients that survived 3 months reported a significant alleviation of pain, and 38% of patients that survived for 6 months ...

Clinical trial finds that adding the chemotherapy pill ...

“We found that the 10-year survival rate was 70% with the combined treatment with temozolomide chemotherapy and radiation, compared to 47% with ...

Radiotherapy for brain metastasis and long-term survival

Our results indicate that RT did not significantly increase the median overall survival of BM patients, although RT was associated with a ...

the outcome of whole brain radiation therapy in the era of ...

For asymptomatic patients, ipilimumab has shown an intracranial response rate of 5–16% (19) and pembrolizumab or nivolumab alone achieved a response rate of 21– ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34119447/

Radiation Therapy for Brain Metastases: A Systematic ...

Radiation therapy after surgery did not improve overall survival compared with surgery alone (HR, 0.98; 95% CI, 0.76%-1.26%; 5 RCTs). Data for ...

Safety Evaluation of a Combination of Brain Radiation ...

None intracerebral hemorrhage or death related to the treatment was reported. These results indicate a possible way of innovative strategies in the therapeutic ...

Efficacy and safety analysis in metastatic cancer patients ...

Response to radiotherapy was observed in 548 (83.0 %) cases and CTCAE toxicity grade > 3 was observed in 21 (3.2 %) cases. •. An increasing number of RT courses ...

Safety and Feasibility of Stereotactic Radiosurgery for ...

SRS was safe, had favorable cognitive outcomes, and had comparable survival outcomes to contemporary studies evaluating WBRT in this population. Treatment-naïve ...

People who experience side effects from cranial radiation ...

Analysis of three large, phase III clinical trials finds more than 40% of brain metastases patients completely reversed cognitive losses.