Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System
Recruiting
Observational Study
CancerCancer Central Nervous SystemCancer ThoracicCancer, GastrointestinalCancer GynecologicCancer, Genito-UrinaryCancers LymphaticCancer Head and Neck
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Any
Study type
Observational
Participants needed
500 (estimated)
Sponsor
RefleXion Medical · Industry
Who this trial is looking for
This trial is looking for patients with certain types of cancer who need radiotherapy. Participants will receive treatment using a special radiotherapy system and will be asked to provide feedback on their experience and side effects.
Are You a Good Fit for This Trial?
You may be able to join if
I can understand and sign a consent form.
I have been diagnosed with cancer that requires radiotherapy.
I will receive radiation treatment using the RefleXion system.
I don't have other health issues that would prevent me from getting radiotherapy.
I am a male or female with child-bearing potential and will take steps to avoid pregnancy.
I am eligible for specific treatments if I am receiving BgRT.
You may not be able to join if
I am pregnant or plan to become pregnant during the study.
I have a psychiatric or substance abuse disorder that affects my ability to participate.
I cannot stay still or lie on my back for the treatment.
I have an allergy to FDG if I am receiving BgRT.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this prospective cohort study is to assess clinical and quality of life measures as well as to define the severity of adverse effects for the use of the RefleXion system to deliver intensity-modulated radiotherapy (IMRT), stereotactic body radiotherapy (SBRT), or SCINTIX Biology-guided radiotherapy (BgRT) in standard of care (SOC) use in the treatment of local,loco-regionally advanc…
The purpose of this prospective cohort study is to assess clinical and quality of life measures as well as to define the severity of adverse effects for the use of the RefleXion system to deliver intensity-modulated radiotherapy (IMRT), stereotactic body radiotherapy (SBRT), or SCINTIX Biology-guided radiotherapy (BgRT) in standard of care (SOC) use in the treatment of local,loco-regionally advanced, and oligometastatic malignancies. In addition, patient costs and charges will be analyzed to quantify the health economic impact of this modality. Workflow and quality of radiotherapy planning including a collection of dosimetric data will also be analyzed.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Able to comprehend and be willing to sign an informed consent form (ICF).
* Diagnosis of local, loco-regionally advanced, or metastatic malignancy for whom radiotherapy is indicated
* Radiotherapy to be delivered on the RMRS X1 with IMRT, SBRT, or BgRT technique.
* Absence of …
Inclusion Criteria:
* Able to comprehend and be willing to sign an informed consent form (ICF).
* Diagnosis of local, loco-regionally advanced, or metastatic malignancy for whom radiotherapy is indicated
* Radiotherapy to be delivered on the RMRS X1 with IMRT, SBRT, or BgRT technique.
* Absence of concurrent illness that deems radiotherapy a contraindication which will be determined by the treating radiation oncologist.
* Female and male patients of child-bearing potential willing to take appropriate precautions to avoid pregnancy while being treated. Permitted methods in preventing pregnancy should be communicated to the patient and their understanding confirmed by the treating Physician.
* For BgRT patients only: Deemed eligible for BgRT with FDG per BgRT planning session
Exclusion Criteria:
* Pregnant or expecting to conceive during the study.
* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with study requirements and follow-up visits.
* Inability to maintain immobilization, supine position for planning and treatments.
* For BgRT patients only: Known allergy to FDG
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