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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to use MRI and PET imaging to enhance radiation therapy for certain cancers. It aims to understand how tumors in head and neck cancer and brain metastases resist treatment, potentially causing cancer recurrence or progression. Participants will undergo imaging with 18F-fluoromisonidazole, a special imaging agent, to identify areas that might not respond well to radiation. Individuals with measurable tumors from head and neck squamous cell carcinoma or brain metastases from other cancers may be suitable for this study. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking advancements in cancer therapy.

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.

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

Research has shown that 18F-fluoromisonidazole, the imaging agent used in this trial, has been studied in several projects. These studies suggest it can help monitor low oxygen levels in tumors and changes related to radiation treatment. However, there isn't enough evidence yet to support its regular use for adjusting radiation doses in head and neck cancer.

MRI (Magnetic Resonance Imaging) is generally well-tolerated because it doesn’t use harmful radiation. It is considered safe for ongoing imaging, which is useful for tracking tumor changes over time.

PET (Positron Emission Tomography) is commonly used in cancer care and has proven to be a safe method for guiding radiation treatment. PET scans involve a small amount of radioactive material, but they are widely used because the benefits for diagnosis and treatment planning outweigh the risks.

Overall, these tools are generally safe and have been used in many studies and clinical settings. They are chosen for trials because they provide important information with a low risk of serious side effects.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it leverages cutting-edge imaging techniques to improve cancer treatment precision. Unlike traditional methods that rely heavily on static imaging, this approach uses 18F-fluoromisonidazole with MRI and PET scans to dynamically assess tumor behavior and response. This could lead to more personalized and effective radiation therapy, potentially improving outcomes for patients with locally advanced squamous cell carcinoma of the head and neck, as well as those with brain metastases. By tailoring treatment in real time, this method could overcome limitations of current standards, offering a promising advancement in cancer care.

What evidence suggests that this trial's treatments could be effective for cancer?

In this trial, participants with locally advanced squamous cell carcinoma of the head and neck or brain metastases will undergo magnetic resonance imaging (MRI) scans and positron emission tomography (PET) scans using the imaging agent 18F-fluoromisonidazole. Research has shown that this special type of scan, called an 18F-fluoromisonidazole PET scan, can help predict the effectiveness of radiation therapy for head-and-neck cancer. This scan identifies low-oxygen areas in tumors, which are often difficult to treat with radiation. Studies have found that detecting these low-oxygen areas before treatment can provide insights into the potential success of the therapy. The scan helps doctors identify tumor parts that might resist treatment, allowing for more effective therapy planning. While promising, further research is needed to confirm these benefits in everyday medical care.13678

Who Is on the Research Team?

EO

Evan Osmundson, MD

Principal Investigator

Vanderbilt University/Ingram Cancer Center

Are You a Good Fit for This Trial?

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 10 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • 18F-fluoromisonidazole
  • Magnetic Resonance Imaging (MRI)
  • Positron Emission Tomography (PET)
Trial Overview The 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Locally Advanced Squamous Cell Carcinoma of the Head and NeckExperimental Treatment3 Interventions
Group II: Brain metastasesExperimental Treatment3 Interventions

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+

Published Research Related to This Trial

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]
Adaptive radiotherapy (ART) enhances treatment accuracy by using real-time MRI to monitor changes in tumor and surrounding structures, allowing for personalized adjustments during radiotherapy without additional radiation exposure.
The integration of functional MRI sequences can provide imaging biomarkers that support both geometric and biological adaptations in treatment, potentially improving outcomes across various tumor types.
Adaptive Radiotherapy Enabled by MRI Guidance.Hunt, A., Hansen, VN., Oelfke, U., et al.[2022]
In a study of 20 head and neck cancer patients, (18)F-fluoromisonidazole ((18)F-FMISO) PET scans showed a strong correlation in intratumor hypoxia distribution in 71% of patients, indicating its potential for identifying hypoxic regions that contribute to radioresistance.
However, when focusing on specific hypoxic zones, only 46% of patients exhibited strong correlation, suggesting variability in (18)F-FMISO uptake and the need for further research to understand these changes before using single-time-point PET scans for hypoxia-targeted radiotherapy.
Reproducibility of intratumor distribution of (18)F-fluoromisonidazole in head and neck cancer.Nehmeh, SA., Lee, NY., Schröder, H., et al.[2021]

Citations

Is there a role for [18F]-FMISO PET to guide dose adaptive ...Combined uptake of [18F]FDG and [18F]FMISO correlates with radiation therapy outcome in head-and-neck cancer patients. Radiother Oncol. 2006;80:151–6. doi ...
Is there a role for [18F]-FMISO PET to guide dose adaptive ...Our results show that currently there is insufficient evidence to propose [ 18 F]FMISO PET for radiotherapy dose adaptation in HNC in a routine clinical ...
Kinetic analysis of dynamic 18F-fluoromisonidazole PET ...Kinetic analysis of dynamic 18F-fluoromisonidazole PET correlates with radiation treatment outcome in head-and-neck cancer - PMC.
A randomized phase II study using dynamic [18F]FMISO ...Kinetic analysis of dynamic 18F-fluoromisonidazole PET correlates with radiation treatment outcome in head-and-neck cancer. BMC Cancer, 5 (2005), p. 152. View ...
Tumor Hypoxia Detected by 18F-fluoromisonidazole ...Tumor hypoxia detected by FMISO PET/CT before RT may predict clinical outcome. Hypoxic tumor cells are considered radioresistant and/or chemoresistant.
18 F-FMISO-based micro PET for imaging of tumor hypoxia ...The present experiments indicate that 18F-HX4 and 18F-FMISO PET/CT could be used as biomarkers for monitoring tumor hypoxia and radiotherapy-associated changes.
A randomized phase II study using dynamic [18F]FMISO ...This study presents results of a randomized phase II trial on hypoxia dose escalation in head and neck cancer (HNC)
[18F] FMISO Imaging post TACE CC ProtocolData collection for this study will include imaging data used to identify acute post-embolization tumor hypoxia, as well as conventional post- ...
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