Three-Dimensional Molds Based on Radiological imagEs in Patients With Cancer: the DIRECT Trial (DIRECT)

August 20, 2026 updated by: Tampere University Hospital
Determination of the sites from which the histopathological samples in surgically removed lesions are collected is still done by eye by a pathologist. As radiological determination of regions of interest has already proven useful in in vivo use cases, the implementation of sampling of ex vivo lesions with the help of radiological imaging suggests great potential. By developing and implementing mold printing processes, these molds have the potential to vastly improve the accuracy and consistency of histopathological sampling and collection of tissue samples from different regions of tumor, leading to improved characterization, more individualized treatments, and eventually better survival.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
      • Tampere, Finland
        • Recruiting
        • Tampere University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study arm
Procedure: 3D-printed tumor mold for tissue sampling
3D-printed tumor mold for tissue sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2. Histopathological evaluation
Time Frame: After the surgery upon review of the histopathological sample (within 3 months of the operation)
Rate of malignant/benign and higher/lower grade tumor tissue in the samples obtained using 3D-molds
After the surgery upon review of the histopathological sample (within 3 months of the operation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker evaluation from the samples obtained using 3D-mold
Time Frame: After the surgery throughout the study period and upon the completion of study recruitment within 3 months
Rate of presentation of biomarkers evaluated from the samples obtained using 3D-molds
After the surgery throughout the study period and upon the completion of study recruitment within 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Collaborators

Kuopio University Hospital
Tampere University
University of Eastern Finland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2024

Primary Completion (Estimated)

December 1, 2033

Study Completion (Estimated)

December 15, 2033

Study Registration Dates

First Submitted

August 10, 2026

First Submitted That Met QC Criteria

August 20, 2026

First Posted (Actual)

August 21, 2026

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R23084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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