Clinical trial Recruiting at 1 site Interventional

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 typeInterventional
SexAll
Enrollment30 (estimated)
SponsorTampere University Hospital
Academic / other
Locations1 site (Tampere)
StatusRecruiting
StartedMay 31, 2024
Main results expectedDecember 2033
Study endsDecember 15, 2033
Registry record updatedAugust 21, 2026
Trial IDNCT07778173 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.