Three-Dimensional Tumor Molds Made from Imaging to Guide Tissue Sampling
Official title: Three-Dimensional Molds Based on Radiological imagEs in Patients With Cancer: the DIRECT Trial
Run by Tampere University Hospital · NCT07778173 · Data updated 2026-11-12
Researchers will test whether 3D-printed molds based on radiology can guide precise tissue sampling from surgically removed tumors.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Tampere University Hospital Academic / other |
| Locations | 1 site (Tampere) |
| Status | Recruiting |
| Started | May 31, 2024 |
| Main results expected | December 2033 |
| Study ends | December 15, 2033 |
| Registry record updated | August 21, 2026 |
| Trial ID | NCT07778173 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (and children capable of assent with guardians) with malignant or likely malignant tumors scheduled for surgery who can provide informed consent.
✕Probably not a fit
Patients whose tumors do not benefit from spatially guided sampling or whose surgical plan changes may not experience a direct sampling advantage.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial uses 3D-printed molds derived from radiologic images to guide where tissue samples are taken from tumors during surgery. The goal is to improve the accuracy and consistency of histopathologic sampling across different tumor regions. The study involves participants with malignant or likely malignant tumors undergoing surgical procedures and aims to see if mold-guided sampling can enhance tumor characterization and potentially support more personalized treatment planning. The design centers on a surgical workflow modification with ex vivo tissue sampling using the printed molds. No phase designation is listed for this interventional study.
Why it matters
Potential benefit: If successful, the approach could improve tumor profiling and inform more tailored treatment decisions.
How similar studies have gone: Similar radiology-guided approaches have shown potential in in vivo settings; this ex vivo mold-based method is a newer application in tissue sampling.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: To be eligible for the study, the study candidate must: * be willing and able to give informed consent and give their written consent for the participation in the study (in case of a child (\<15-year-old), the consent is collected in an age-appropriate manner from the study candidate and their legal guardian(s)) * have a malignant or likely malignant tumor/tumors and undergo a surgical operation. Exclusion Criteria: To be eligible for the study, the study candidate cannot: * lack the capacity to provide informed consent (if a legal guardian objects to the participation of their child (\<15-year-old), the child is not eligible); * be at risk of having their standard of care treatment jeopardized by the study, in the opinion of their physician.
Where it's running
-
Tampere University Hospital
Tampere, Finland Recruiting
Study contacts
- Study coordinator: Otso Arponen, MD
- Email: otso.arponen@tuni.fi
- Phone: +359 3 311 611
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.