48 Participants Needed

Adaptive Radiation Therapy for Cancer

VS
Overseen ByVanderbilt-Ingram Services for Timely Access
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Vanderbilt-Ingram Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This study will apply novel MRI approaches with established sensitivity to tissue oxygen consumption and perfusion to predict hypoxia-associated radiation resistance, manifested as tumor recurrence and progression post-treatment.

Do I need to stop my current medications for this 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.

What data supports the effectiveness of the treatment involving 18F-fluoromisonidazole (FMISO) and imaging techniques like MRI and PET scans for cancer?

Research shows that 18F-fluoromisonidazole (FMISO) is effective in identifying hypoxic (low oxygen) areas in tumors, which are often more resistant to radiation therapy. This imaging helps doctors better target these areas during treatment, potentially improving the effectiveness of radiotherapy for cancer.12345

Is MRI safe for use in humans?

MRI (Magnetic Resonance Imaging) is generally considered safe for humans, as it is widely used for breast cancer screening, especially in women at high risk. However, there are concerns about false-positive findings, which can lead to unnecessary stress and additional testing.678910

How is adaptive radiation therapy different from other cancer treatments?

Adaptive radiation therapy is unique because it uses real-time MRI guidance to adjust the treatment plan during the course of therapy, allowing for more precise targeting of the tumor while minimizing radiation exposure to surrounding healthy tissues. This approach provides superior soft-tissue contrast and enables personalized treatment adjustments based on anatomical and biological changes, which is not possible with traditional X-ray-based radiotherapy.1112131415

Research Team

EO

Evan Osmundson, MD

Principal Investigator

Vanderbilt University/Ingram Cancer Center

Eligibility Criteria

This trial is for adults with certain head and neck cancers or brain tumors, who can be measured by scans, have a life expectancy over 6 months, and are in good physical condition. They must not be pregnant, agree to use birth control, and able to consent.

Inclusion Criteria

I have a tumor that can be measured with a scan or clinical exam.
Agreement to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and up until the day after 18F-FMISO administration. Informing treating physician immediately if pregnancy is suspected
I am mostly able to care for myself and carry out daily activities.
See 3 more

Exclusion Criteria

My brain tumor is larger than 3.0 cm.
Pregnant patients
You can't have an MRI if you're very scared of small spaces, have metal objects inside you, or weigh more than 350 pounds.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment Assessment

Participants undergo MRI and PET scans to assess tumor hypoxia using 18F-fluoromisonidazole

1-2 weeks

Treatment

Participants receive standard of care stereotactic radiosurgery guided by MRI-based markers of tumor hypoxia

6-8 weeks

Follow-up

Participants are monitored for tumor recurrence, progression, and radiation necrosis post-treatment

3 months

Long-term Follow-up

Participants are evaluated for long-term effects of treatment on tumor hypoxia and radiation necrosis

4 years

Treatment Details

Interventions

  • 18F-fluoromisonidazole
  • Magnetic Resonance Imaging (MRI)
  • Positron Emission Tomography (PET)
Trial OverviewThe study tests if new MRI methods combined with PET scans using a tracer called 18F-fluoromisonidazole can predict tumor resistance to radiation therapy due to low oxygen levels in the tumor.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Locally Advanced Squamous Cell Carcinoma of the Head and NeckExperimental Treatment3 Interventions
Participants will undergo magnetic resonance imaging (MRI) scans and positron emission tomography (PET) scans and administered the imaging agent 18F-fluoromisonidazole.
Group II: Brain metastasesExperimental Treatment3 Interventions
Participants will undergo magnetic resonance imaging (MRI) scans and positron emission tomography (PET) scans and administered the imaging agent 18F-fluoromisonidazole.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt-Ingram Cancer Center

Lead Sponsor

Trials
221
Recruited
64,400+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Findings from Research

In a study of 19 acute ischemic stroke patients, FMISO PET scans were able to predict early infarct growth with a sensitivity of 100% and a specificity of 82%, indicating its potential as a reliable imaging tool.
The results showed that increased FMISO uptake was significantly associated with infarct growth, as 8 out of 10 patients with high FMISO uptake experienced growth, while none of the 9 patients without uptake showed any growth.
(18)F-fluoromisonidazole (FMISO) Positron Emission Tomography (PET) Predicts Early Infarct Growth in Patients with Acute Ischemic Stroke.Lee, GH., Kim, JS., Oh, SJ., et al.[2017]
Fluorine-18 fluoromisonidazole (FMISO) effectively identifies hypoxic and radioresistant tumors, showing significantly higher uptake in these tumors compared to control tumors, which suggests its potential as a reliable imaging agent in cancer diagnostics.
The study found that FMISO uptake inversely correlates with methionine uptake, indicating that areas of high FMISO uptake correspond to low metabolic activity, while 2-deoxyglucose (2DG) showed a more uniform distribution, suggesting that combining FMISO with other tracers could enhance the prediction of tumor response to radiotherapy.
Comparison of the distribution of fluorine-18 fluoromisonidazole, deoxyglucose and methionine in tumour tissue.Kubota, K., Tada, M., Yamada, S., et al.[2019]
In a study of 22 patients undergoing radiotherapy, tumor hypoxia identified by 18F-misonidazole PET/CT before treatment was significantly correlated with initial tumor response, indicating its potential as a predictive biomarker for clinical outcomes.
Patients with lower levels of hypoxia (measured by SUVmax, T/M ratios, and hypoxic volume) had significantly better overall survival and loco-regional control rates compared to those with higher levels, suggesting that assessing tumor hypoxia can guide treatment strategies.
Tumor Hypoxia Detected by 18F-fluoromisonidazole Positron Emission Tomography (FMISO PET) as a Prognostic Indicator of Radiotherapy (RT).Tachibana, I., Nishimura, Y., Hanaoka, K., et al.[2018]

References

(18)F-fluoromisonidazole (FMISO) Positron Emission Tomography (PET) Predicts Early Infarct Growth in Patients with Acute Ischemic Stroke. [2017]
Comparison of the distribution of fluorine-18 fluoromisonidazole, deoxyglucose and methionine in tumour tissue. [2019]
Tumor Hypoxia Detected by 18F-fluoromisonidazole Positron Emission Tomography (FMISO PET) as a Prognostic Indicator of Radiotherapy (RT). [2018]
Synthesis of [18F]FMISO, a hypoxia-specific imaging probe for PET, an overview from a radiochemist's perspective. [2023]
Reproducibility of intratumor distribution of (18)F-fluoromisonidazole in head and neck cancer. [2021]
Breast cancer screening in women at high risk using MRI. [2009]
Time-Related Changes in Yield and Harms of Screening Breast Magnetic Resonance Imaging. [2015]
Clinical Breast Magnetic Resonance Imaging: Technique, Indications, and Future Applications. [2018]
Systematic review: using magnetic resonance imaging to screen women at high risk for breast cancer. [2022]
MRI breast screening in high-risk women: cancer detection and survival analysis. [2022]
Target Definition in MR-Guided Adaptive Radiotherapy for Head and Neck Cancer. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Magnetic resonance-guided adaptive radiotherapy: a solution to the future. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Development and clinical application of a GPU-based Monte Carlo dose verification module and software for 1.5 T MR-LINAC. [2023]
Adaptive Radiotherapy Enabled by MRI Guidance. [2022]
Exploring MR regression patterns in rectal cancer during neoadjuvant radiochemotherapy with daily T2- and diffusion-weighted MRI. [2021]