Thoracic CancerNCT06634706
SCINTIX [BgRT} Using RMRS in Solid and Soft Tissue Tumors
A study testing RefleXion X1 Radiotherapy System [Imaging Only] in people with Thoracic Cancer and Head and Neck Cancer, run by RefleXion Medical.
Trial summary
This study proposes 6 anatomic groupings which each can be defined similarly as the "head and neck" grouping above. These 6 groupings are: (1) Head and Neck, (2) Thoracic not including lung parenchymal, (3) Hepatobiliary and other non-hepatobiliary abdominal tumors, (4) Retroperitoneal, (5) Pelvic, and (6) Distributed… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Thoracic Cancer, Head and Neck Cancer, Pelvic Cancer
- What is being tested?
- RefleXion X1 Radiotherapy System [Imaging Only]
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 21 years.
- A new or prior diagnosis of biopsy-proven cancer.
- At least one active non-osseous primary or metastatic tumor that is located in one of the assigned anatomical groupings and dispositioned to undergo 3-5 fractions of SBRT. A lesion is considered active if viable malignancy is confirmed either by biopsy or by diagnostic imaging (as interpreted by the multidisciplinary care team).
- Target tumor size ≥2cm and ≤5cm.
- Target tumor is discrete and assessed by investigator to meet diagnostic PET screening criteria for BgRT candidacy:
- SUVmax≥6, as assessed on diagnostic PET/CT performed within 60 days of enrollment with no new intervening oncologic therapies.
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- Ratio of target tumor SUVmax to SUVmean of local background region (defined as a 3 mm shell 1.5 cm from the target tumor) is greater than 6, as assessed on diagnostic PET/CT performed within 60 days of enrollment with no new intervening oncologic therapies.
- ECOG Performance Status 0-3.
- Must have completed any other oncologic therapies at least 15 days prior to planned start of study procedures (preferably 30 days) and must have no plans to initiate systemic therapy until after study follow up is complete -OR- must be recorded by physician to have an active lesion that is unresponsive to ongoing systemic therapy.
- Females of childbearing potential should have a negative urine or serum pregnancy test within 14 days prior to initiation of study scans.
Who cannot join
- Clinically significant blood glucose abnormalities that preclude a satisfactory FDG PET/CT scan.
- Lung parenchymal and bone target tumors
- At the physician's discretion regarding expected target motion, FDG-avid structures not intended for radiation are within:
- 3 cm from target on diagnostic PET/CT in directions where limited target motion is expected
- 4 cm from target on diagnostic PET/CT in directions where sizable target motion is expected
- Known allergy to FDG.
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- Known psychiatric or substance abuse disorder that would interfere with conduct of the study.
- Pregnant, breast-feeding or expecting to conceive during the study.
- Patient weight exceeding the weight limit outlined per user manual.
- Patients with pacemakers and other implantable devices deemed at high risk by the treating physician for complications secondary to radiotherapy, according to institutional guidelines and published guidelines (e.g. AAPM task group-203).
- Active inflammatory bowel disease, scleroderma, or other disorder deemed by the treating physician to put the patient at risk for excess toxicity in the setting of external beam radiation therapy (EBRT) or FDG injection.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mario Esquivel contact
About this study
Official title: Performance and Safety of Biology-Guided Radiotherapy Using the RefleXion Medical Radiotherapy System in in a Variety of Solid and Soft Tissue Tumors (BIOGUIDE-X2)
This study proposes 6 anatomic groupings which each can be defined similarly as the "head and neck" grouping above. These 6 groupings are: (1) Head and Neck, (2) Thoracic not including lung parenchymal, (3) Hepatobiliary and other non-hepatobiliary abdominal tumors, (4) Retroperitoneal, (5) Pelvic, and (6) Distributed or orphan. The study is designed to gather essential imaging data on the RefleXion Medical Radiotherapy System (RMRS) to validate the accuracy of FDG-directed BgRT, also known as SCINTIX therapy, in various anatomical groupings. Study subjects will go through the entire SCINTIX treatment workflow, including radiopharmaceutical administration and live PET imaging, but without turning on the treatment beam. Collected data will be used offline to generate the set of machine instructions that would have been used during treatment delivery to calculate the "emulated" BgRT dose distribution, i.e., what the delivered dose would have been had the treatment beam been turned on during the session. The 6th category ("Distributed or orphan") is meant to capture tumor types that can manifest across anatomies and/or for which utilization of stereotactic radiotherapy for treatment is relatively rare, with lymphomas being a prototypical example.
Read the detailed description
Ablative radiotherapy has become an integral tool for the treatment of primary tumors and metastatic lesions across the human body. Because ablative radiotherapy techniques like stereotactic body radiotherapy (SBRT) and stereotactic radiosurgery (SRS) involve delivering high doses of radiotherapy in a few fractions, they have the potential to cause serious injury to normal tissues near the target lesion. Therefore, a standard concern for radiation oncologists is to conformally and precisely deliver ablative radiotherapy while maximally sparing surrounding organs and tissues. This goal is relevant throughout the anatomy and pertains as much to tumors in the head and neck as it does to those in the pelvis.
Biology-guided radiotherapy is a novel radiotherapy delivery mechanism that achieves precision by aiming beamlets of external radiotherapy by tracking PET emissions that originate from the target after it has taken up an injected radiotracer. Because the radiotherapy beamlets are guided to the tumor in real-time, this technology holds strong promise for reducing margins around the target and thereby reducing normal tissue toxicities.
- Conditions
- Thoracic Cancer, Head and Neck Cancer, Pelvic Cancer, Hepatobiliary Carcinoma in Situ, Retroperitoneal Cancer, Distributed and Orphan Tumors
- Being tested
- RefleXion X1 Radiotherapy System [Imaging Only]
- Medical subject headings
- Head and Neck Neoplasms, Pelvic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RefleXion X1 Radiotherapy System [Imaging Only]Device
Also called RefleXion Medical Radiotherapy System
kVCT and FDG-PET imaging using the RefleXion X1 Radiotherapy System in different anatomical regions
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Head and Neck Tumors | Other | Tumors in the following regions: Larynx, Salivary glands, Thyroid gland, Head and Neck lymph nodes, Oral cavity, Oropharynx, Nasopharynx, and Hypopharynx Receives: Device: RefleXion X1 Radiotherapy System [Imaging Only] |
| Cohort 2 - Thoracic Tumors | Other | Tumors in the following regions: Thoracic lymph nodes, Thymus, Esophagus, and Breast, Receives: Device: RefleXion X1 Radiotherapy System [Imaging Only] |
| Cohort 3 - Hepatobiliary Tumors | Other | Tumors in the following regions: Liver and intrahepatic ducts, Gallbladder, Extrahepatic bile ducts, and Hepatic lymph nodes, Receives: Device: RefleXion X1 Radiotherapy System [Imaging Only] |
| Cohort 4 - Retroperitoneal Tumors & non-Hepatobiliary Abdominal Tumors | Other | Tumors in the following regions: Kidneys, Adrenal gland, Pancreas, Retroperitoneal lymph nodes, Stomach, Spleen, Small intestine, and Colon Receives: Device: RefleXion X1 Radiotherapy System [Imaging Only] |
| Cohort 5 - Pelvic Tumors | Other | Tumors in the following regions: Prostate, Bladder, Ureter, Urethra, Cervix, Ovaries, Fallopian tubes, Vagina, Colon [Sigmoid], Rectum, Anus, and Pelvic lymph nodes. Receives: Device: RefleXion X1 Radiotherapy System [Imaging Only] |
| Cohort 6 - Other and Orphan Tumors | Other | Tumors in the following regions: * Locations not listed in Cohorts 1-5, however; considered at physicians discretion i.e. Lymphoma [Head and Neck], Thorax, Abdomen, and Pelvis Receives: Device: RefleXion X1 Radiotherapy System [Imaging Only] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emulated BgRT Delivery accuracy
The percent of radiotherapy fractions where the emulated BgRT dose distribution is shown to be consistent with the approved BgRT treatment plan (i.e., 95% of DVHDelivered points for the BTZ and OAR fall within bounded DVH of the approved BgRT plan).
Measured: Assessed for each emulated delivery through study completion, an average of 2 years
Secondary outcomes (1)
BgRT deliverability
Percent of fractions where there is concordance between physical and digital phantoms of emulated BgRT delivery derived from human subject PET emissions. Concordance is defined as a standard gamma index of 90% of pixels meeting the 3mm/3% deviation standard.
Measured: Assessed for each emulated delivery through study completion,an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Dec 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RefleXion Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean S. Shirvani, MD, Study director, RefleXion Medical Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634706
- Sponsor's protocol ID
- 985-00007
- Status last verified
- Aug 2025
- First submitted
- 26 Sep 2024
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Safety of Biology-Guided Radiotherapy Using the RefleXion Medical Radiotherapy System in in a Variety of Solid and Soft Tissue Tumors (BIOGUIDE-X2)
- ClinicalTrials.gov ID
- NCT06634706
- Acronym / sponsor ID
- 985-00007
- Conditions
- Thoracic Cancer, Head and Neck Cancer, Pelvic Cancer, Hepatobiliary Carcinoma in Situ, Retroperitoneal Cancer, Distributed and Orphan Tumors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- RefleXion MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study proposes 6 anatomic groupings which each can be defined similarly as the "head and neck" grouping above. These 6 groupings are: (1) Head and Neck, (2) Thoracic not including lung parenchymal, (3) Hepatobiliary and other non-hepatobiliary abdominal tumors, (4) Retroperitoneal, (5) Pelvic, and (6) Distributed or orphan. The study is designed to gather essential imaging data on the RefleXion Medical Radiotherapy System (RMRS) to validate the accuracy of FDG-directed BgRT, also known as SCINTIX therapy, in various anatomical groupings. Study subjects will go through the entire SCINTIX treatment workflow, including radiopharmaceutical administration and live PET imaging, but without turning on the treatment beam. Collected data will be used offline to generate the set of machine instructions that would have been used during treatment delivery to calculate the "emulated" BgRT dose distribution, i.e., what the delivered dose would have been had the treatment beam been turned on during the session. The 6th category ("Distributed or orphan") is meant to capture tumor types that can manifest across anatomies and/or for which utilization of stereotactic radiotherapy for treatment is relatively rare, with lymphomas being a prototypical example.
Detailed description
Ablative radiotherapy has become an integral tool for the treatment of primary tumors and metastatic lesions across the human body. Because ablative radiotherapy techniques like stereotactic body radiotherapy (SBRT) and stereotactic radiosurgery (SRS) involve delivering high doses of radiotherapy in a few fractions, they have the potential to cause serious injury to normal tissues near the target lesion. Therefore, a standard concern for radiation oncologists is to conformally and precisely deliver ablative radiotherapy while maximally sparing surrounding organs and tissues. This goal is relevant throughout the anatomy and pertains as much to tumors in the head and neck as it does to those in the pelvis.
Biology-guided radiotherapy is a novel radiotherapy delivery mechanism that achieves precision by aiming beamlets of external radiotherapy by tracking PET emissions that originate from the target after it has taken up an injected radiotracer. Because the radiotherapy beamlets are guided to the tumor in real-time, this technology holds strong promise for reducing margins around the target and thereby reducing normal tissue toxicities.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Head and Neck Tumors | Other | Device: RefleXion X1 Radiotherapy System [Imaging Only]Tumors in the following regions: Larynx, Salivary glands, Thyroid gland, Head and Neck lymph nodes, Oral cavity, Oropharynx, Nasopharynx, and Hypopharynx |
| Cohort 2 - Thoracic Tumors | Other | Device: RefleXion X1 Radiotherapy System [Imaging Only]Tumors in the following regions: Thoracic lymph nodes, Thymus, Esophagus, and Breast, |
| Cohort 3 - Hepatobiliary Tumors | Other | Device: RefleXion X1 Radiotherapy System [Imaging Only]Tumors in the following regions: Liver and intrahepatic ducts, Gallbladder, Extrahepatic bile ducts, and Hepatic lymph nodes, |
| Cohort 4 - Retroperitoneal Tumors & non-Hepatobiliary Abdominal Tumors | Other | Device: RefleXion X1 Radiotherapy System [Imaging Only]Tumors in the following regions: Kidneys, Adrenal gland, Pancreas, Retroperitoneal lymph nodes, Stomach, Spleen, Small intestine, and Colon |
| Cohort 5 - Pelvic Tumors | Other | Device: RefleXion X1 Radiotherapy System [Imaging Only]Tumors in the following regions: Prostate, Bladder, Ureter, Urethra, Cervix, Ovaries, Fallopian tubes, Vagina, Colon [Sigmoid], Rectum, Anus, and Pelvic lymph nodes. |
| Cohort 6 - Other and Orphan Tumors | Other | Device: RefleXion X1 Radiotherapy System [Imaging Only]Tumors in the following regions: * Locations not listed in Cohorts 1-5, however; considered at physicians discretion i.e. Lymphoma [Head and Neck], Thorax, Abdomen, and Pelvis |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age greater than 21 years.
- A new or prior diagnosis of biopsy-proven cancer.
- At least one active non-osseous primary or metastatic tumor that is located in one of the assigned anatomical groupings and dispositioned to undergo 3-5 fractions of SBRT. A lesion is considered active if viable malignancy is confirmed either by biopsy or by diagnostic imaging (as interpreted by the multidisciplinary care team).
- Target tumor size ≥2cm and ≤5cm.
- Target tumor is discrete and assessed by investigator to meet diagnostic PET screening criteria for BgRT candidacy:
Key exclusion criteria (11 listed)
- Clinically significant blood glucose abnormalities that preclude a satisfactory FDG PET/CT scan.
- Lung parenchymal and bone target tumors
- At the physician's discretion regarding expected target motion, FDG-avid structures not intended for radiation are within:
- Known allergy to FDG.
- Known psychiatric or substance abuse disorder that would interfere with conduct of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RefleXion X1 Radiotherapy System [Imaging Only]Also: RefleXion Medical Radiotherapy SystemkVCT and FDG-PET imaging using the RefleXion X1 Radiotherapy System in different anatomical regions | Device | Cohort 1 - Head and Neck Tumors, Cohort 2 - Thoracic Tumors, Cohort 3 - Hepatobiliary Tumors, Cohort 4 - Retroperitoneal Tumors & non-Hepatobiliary Abdominal Tumors, Cohort 5 - Pelvic Tumors, Cohort 6 - Other and Orphan Tumors |
Primary outcome
Emulated BgRT Delivery accuracy
Time frame: Assessed for each emulated delivery through study completion, an average of 2 years
The percent of radiotherapy fractions where the emulated BgRT dose distribution is shown to be consistent with the approved BgRT treatment plan (i.e., 95% of DVHDelivered points for the BTZ and OAR fall within bounded DVH of the approved BgRT plan).
1 secondary outcome
BgRT deliverability
Time frame: Assessed for each emulated delivery through study completion,an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mario Esquivel contact
Sean S. Shirvani, MD study director
RefleXion Medical Inc
Questions about this trial
What is this clinical trial studying?
A study testing RefleXion X1 Radiotherapy System [Imaging Only] in people with Thoracic Cancer and Head and Neck Cancer, run by RefleXion Medical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Debradenise S. Brooks (6504828435, dbrooks@reflexion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emulated BgRT Delivery accuracy (time frame: Assessed for each emulated delivery through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.