Magnetic Resonance Guided Adaptive Stereotactic Body Radiotherapy for Lung Tumors in Ultracentral Location
New MRI-guided radiation therapy for hard-to-reach lung tumors
Plain English Summary
Magnetic Resonance Guided Adaptive Stereotactic Body Radiotherapy for Lung Tumors in Ultracentral Location is a Phase 1 clinical trial sponsored by University Hospital Heidelberg studying Lung Cancer. This trial tests a new type of radiation therapy called MR-guided adaptive stereotactic body radiotherapy (SBRT) for lung tumors. It is for patients with lung tumors located in a very specific, difficult-to-treat area near the lungs' major airways or esophagus. Participation involves receiving this specialized radiation therapy, with daily adjustments to the treatment plan based on MRI scans, and regular follow-up appointments. Alternative treatments may include standard SBRT, chemotherapy, or surgery, depending on the tumor's characteristics and the patient's overall health. The trial aims to enroll 38 participants.
Official Summary
MAGELLAN is a phase-I dose escalation trial that aims to identify the maximum tolerated dose (MTD) of MR-guided SBRT of ultracentral lung Tumors (primary objective). Thus, a maximum of 38 patients with ultracentral lung tumors (overlap of the planning target volume with the proximal bronchial tree and/or esophagus) will receive MR-guided SBRT including gated dose delivery and daily plan adaptation on a 0.35 MR-linac System. Dose levels are as follows: * 0 (de-escalation): 10 x 5.0Gy * 1 (start): 10 x 5.5Gy * 2: 10 x 6.0Gy * 3: 10 x 6.5Gy Dose escalation is performed according to a time-to-event continual reassessment method (TITE-CRM) with backup element. Patients are observed individually for 12 months to detect potential dose limiting toxicity (DLT = primary endpoint) and for a total of 24 months to detect potential tumor relapse.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with lung tumors in an 'ultracentral' location (near airways or esophagus) can join. Tumors must be less than 5cm in diameter. Patients must be over 18, in good general health (Karnofsky score >70%), and able to lie still and hold their breath for extended periods. Patients with previous lung radiation in the same area, recent radiation side effects, or contraindications to MRI (like pacemakers) cannot participate. This trial is studying Lung Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
The main goal is to find the highest safe dose of this new radiation therapy by monitoring for serious side effects, ensuring the treatment is as effective as possible while minimizing harm. The specific primary outcome measures are: Dose limiting toxicity (DLT) (For 12 months from the beginning of SBRT.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.
Why This Trial Matters
This trial explores a cutting-edge radiation technique that uses MRI to precisely target and adapt treatment for challenging lung tumors, potentially improving outcomes where traditional methods are l This research targets Lung Cancer, where improved treatment options are needed.
Investor Insight
This early-phase trial investigates a novel approach to lung cancer treatment, potentially paving the way for more precise and effective therapies in a significant patient population. Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if your tumor is in an 'ultracentral' location and if this MR-guided SBRT is a suitable option for you. Be prepared for daily radiation sessions where the treatment plan may be adjusted using MRI scans. You will need to be able to lie still for about an hour and hold your breath for over 20 seconds during treatment. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SEQUENTIAL
- Masking: NONE
- Enrollment: 38 participants
Interventions
- RADIATION: Stereotactic body radiotherapy (SBRT) — * level 0 (de-escalation): 10 x 5.0Gy * level 1 (start): 10 x 5.5Gy * level 2: 10 x 6.0Gy * level 3: 10 x 6.5Gy
Primary Outcomes
- Dose limiting toxicity (DLT) (For 12 months from the beginning of SBRT.)
Secondary Outcomes
- Local tumor control (For 24 months upon enrollment)
- Regional tumor control (For 24 months upon enrollment)
- Distant tumor Control (For 24 months upon enrollment)
- Progression-free survival (For 24 months upon enrollment)
- Overall survival (For 24 months upon enrollment)
Full Eligibility Criteria
Inclusion Criteria: * ultracentral location of the lung tumor, which is defined as an expected contact or overlap of the planning target volume with the proximal bronchial tree or esophagus at the time of consultation * indication for SBRT of the ultracentral pulmonary tumor * maximum diameter of the ultracentral pulmonary tumor \< 5cm * age \> 18 years of age * Karnofsky Performance Score \> 70% (ECOG Score 0 - 2) * ability to lie still on the MR-linac table for at least one hour * ability to hold one's breath for more than 20 seconds * successful completion of MRgRT simulation * for women with childbearing potential, adequate contraception. * ability of subject to understand character and individual consequences of the clinical trial * written informed consent (must be available before enrolment in the trial) Exclusion Criteria: * refusal of the patients to take part in the study * previous radiotherapy of the lung and mediastinum, if previous and current target volumes overlap * patients who have not yet recovered from acute toxicities of prior therapies * (planned) treatment with vascular endothelial growth factor (VEGF) inhibitors, e.g. Bevacizumab, within the time interval 2 weeks before and 2 weeks after SBRT * pregnant or lactating women * contraindications against performing MRI scans (pacemakers, other implants making MRI impossible) * participation in another competing clinical study or observation period of competing trials
Trial Locations
- University Hospital of Heidelberg, Radiation Oncology, Heidelberg, Germany
Frequently Asked Questions
What is clinical trial NCT04925583?
NCT04925583 is a Phase 1 INTERVENTIONAL study titled "Magnetic Resonance Guided Adaptive Stereotactic Body Radiotherapy for Lung Tumors in Ultracentral Location." It is currently active, not recruiting and is sponsored by University Hospital Heidelberg. The trial targets enrollment of 38 participants.
What conditions does NCT04925583 study?
This trial investigates treatments for Lung Cancer. The primary condition under study is Lung Cancer.
What treatments are being tested in NCT04925583?
The interventions being studied include: Stereotactic body radiotherapy (SBRT) (RADIATION). * level 0 (de-escalation): 10 x 5.0Gy * level 1 (start): 10 x 5.5Gy * level 2: 10 x 6.0Gy * level 3: 10 x 6.5Gy
What does Phase 1 mean for NCT04925583?
Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.
What is the current status of NCT04925583?
This trial is currently "Active, Not Recruiting." It started on 2021-11-01. The estimated completion date is 2030-11-01.
Who is sponsoring NCT04925583?
NCT04925583 is sponsored by University Hospital Heidelberg. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04925583?
The trial aims to enroll 38 participants. The trial status is active, not recruiting.
How is NCT04925583 designed?
This is a interventional study, uses na allocation, follows a sequential design, employs none masking.
What are the primary outcomes being measured in NCT04925583?
The primary outcome measures are: Dose limiting toxicity (DLT) (For 12 months from the beginning of SBRT.). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04925583 being conducted?
This trial is being conducted at 1 site, including Heidelberg (Germany).
Where can I find official information about NCT04925583?
The official record for NCT04925583 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04925583. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04925583 testing in simple terms?
This trial tests a new type of radiation therapy called MR-guided adaptive stereotactic body radiotherapy (SBRT) for lung tumors. It is for patients with lung tumors located in a very specific, difficult-to-treat area near the lungs' major airways or esophagus.
Why is this trial significant?
This trial explores a cutting-edge radiation technique that uses MRI to precisely target and adapt treatment for challenging lung tumors, potentially improving outcomes where traditional methods are l
What are the potential risks of participating in NCT04925583?
The most significant risk is dose-limiting toxicity, which refers to severe side effects that might stop the treatment. Potential side effects are related to radiation, and could include inflammation or damage to nearby healthy tissues like the esophagus or airways. As this is a dose-escalation study, higher doses may carry a greater risk of side effects. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04925583?
Ask your doctor if your tumor is in an 'ultracentral' location and if this MR-guided SBRT is a suitable option for you. Be prepared for daily radiation sessions where the treatment plan may be adjusted using MRI scans. You will need to be able to lie still for about an hour and hold your breath for over 20 seconds during treatment. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04925583 signal from an investment perspective?
This early-phase trial investigates a novel approach to lung cancer treatment, potentially paving the way for more precise and effective therapies in a significant patient population. This is a Phase 1 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves receiving this specialized radiation therapy, with daily adjustments to the treatment plan based on MRI scans, and regular follow-up appointments. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.