Changeflow GovPing Pharma & Drug Safety MR-guided adaptive stereotactic radiotherapy fo...
Routine Notice Added Final

MR-guided adaptive stereotactic radiotherapy for endometrial cancer, Radboud University

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Published July 2nd, 2024
Detected April 7th, 2026
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Summary

The National Library of Medicine registered a new clinical trial (NCT07514325) on ClinicalTrials.gov studying MR-guided adaptive stereotactic radiotherapy for endometrial cancer. The single-arm study will enroll an estimated 20 participants at Radboud University Medical Center in the Netherlands to evaluate feasibility and toxicity outcomes of adaptive radiotherapy guided by MRI imaging.

What changed

ClinicalTrials.gov published a new interventional study registration for a Phase 2 single-arm trial evaluating MR-guided adaptive stereotactic radiotherapy in patients with endometrial cancer after surgery. The study will assess feasibility, acute and late toxicity, and quality of life outcomes at Radboud University Medical Center. Estimated enrollment is 20 participants with completion expected in 2026.

For affected parties including clinical investigators and research coordinators, this registration establishes public accountability requirements under FDAAA 801. Sponsors must update trial status within 30 days of any change and submit results within 12 months of primary completion. Research institutions conducting oncology radiotherapy trials should ensure compliance with ClinicalTrials.gov registration and reporting timelines to avoid civil monetary penalties.

What to do next

  1. Ensure IRB/IEC approval and Good Clinical Practice compliance
  2. Register on ClinicalTrials.gov before enrolling participants under FDAAA 801 requirements
  3. Maintain accurate trial status updates including enrollment numbers and outcome data

Source document (simplified)

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Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
NLM
Published
July 2nd, 2024
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07514325

Who this affects

Applies to
Healthcare providers Clinical investigators Research institutions
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Radiation oncology research Cancer treatment study
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Medical Devices Public Health Pharmaceuticals

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