Changing the dose mid-treatment — an AI workflow registered as radiation
In radiotherapy for glioma, MRI and PET are performed twice during treatment and the dose altered according to what they show, with an AI workflow carrying out the alteration. The registered intervention is radiation.
Trial overview (primary data)
- StatusRecruiting
- ConditionsDiffuse Glioma, Glioblastoma, Adaptive Radiotherapy, Artificial Intelligence
- InterventionsRADIATION: Adaptive radiotherapy
- SponsorTata Memorial Centre
- Target enrollment60 participants
- Period2026-07-27 〜 2028-07-30
Key points
- Gliomas are common primary brain tumors in adults, standardly treated by surgery followed by radiation and chemotherapy.
- Standard practice delivers a uniform dose to the disease area with MRI before and after treatment.
- This trial performs interval imaging with MRI and PET twice during the course of treatment, followed by dose modifications.
- CT, MRI and PET are combined and specific doses delivered to specific areas based on PET, with modification carried out with the help of artificial intelligence.
- The phase is 2, target enrolment 60, the sponsor Tata Memorial Centre, with completion expected 30 July 2028.
1Changing the plan while treatment runs
Standard radiotherapy delivers a uniform dose to the disease area, with MRI before and after. What this registration changes is the middle. Twice during the course, MRI and PET are performed and the dose altered according to what they show, and an AI workflow carries out that alteration.
2Standard practice against this trial
What the AI carries is the workflow deciding how the dose changes. The registration states that creating an artificial intelligence framework in radiation oncology promises to improve the quality of workflow, treatment planning and delivery.
3What is expected to improve
- 1Tumor controlConcentrating dose on resistant areas is expected to control the tumor better
- 2ToxicityTreatment-related toxicities are expected to fall
- 3PrecisionDoses to organs at risk are adjusted as the disease changes
- 4ComplianceBetter treatment compliance is expected to follow from the above
Raising the dose and lowering it appear together. More where the disease resists, less where tissue must be spared. That is what adaptive radiotherapy means.
4The eight boxes side by side
| The registered box | What the AI carried | The registration |
|---|---|---|
| No intervention, observational | Analysing recorded video after the fact | Embryo morphokinetics (NCT07611448) |
| Diagnostic test | Built into the process of testing itself | Cervical cancer screening (NCT06042543) |
| Device | An approved product evaluated in practice | Osteoporosis diagnosis (NCT07620834) |
| Behavioural | One part of the machinery supporting a programme | Stoma and sleep (NCT07805226) |
| Other | A tool clinicians consult | Residents and language models (NCT07199231) |
| Procedure | Taking over the operation of image acquisition | Second-trimester ultrasound (NCT07286591) |
| Drug | Deciding who enters the trial | Postoperative opioid use (NCT07672015) |
| Radiation | Carrying the workflow of dose modification | Adaptive radiotherapy for glioma (NCT06492486) |
Set out together, what shows is that one thing called medical AI is recorded on the register in eight different ways. And the box settles the framework of assessment that applies. Phases cluster in the drug and radiation boxes and cover only 32 of 776 registrations (4.1%) overall.
Registrations as a device come to 14.6%, while the largest share, 26.3%, sits in the box marked other, which says nothing at all as a classification.
Anyone counting how AI is used in medicine from the register runs first into this instability of classification, because what is recorded is not what an AI does but which box the registrant chose.
Why it matters
One thing called medical AI is recorded on the trial register in eight different ways, and the box chosen settles which framework of assessment applies. Phases cluster in the drug and radiation boxes and reach only 32 of 776 registrations (4.1%); device registrations come to 14.6%, while the largest share sits in other, which classifies nothing. Counting how AI is used in medicine from the register means meeting this instability first.
FAQ
What is adaptive radiotherapy?
What does the AI carry?
What benefits are expected?
Sources (primary)
Source: ClinicalTrials.gov (U.S. NIH/NLM, public domain). This site does not provide medical advice. Verify the latest and exact details with the official source. This site is not endorsed or certified by the NIH/NLM.
- ClinicalTrials.gov (study record, original)
- NCT ID: NCT06492486