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

NCT07778173 | Recruiting

• 1 other identifier: R23084
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Tumor

Outcome Measures

Primary Outcomes (1)

• 2. Histopathological evaluation

  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 Outcomes (1)

• Biomarker evaluation from the samples obtained using 3D-mold

  After the surgery throughout the study period and upon the completion of study recruitment within 3 months

Study Arms (1)

Study arm

EXPERIMENTAL

Procedure: 3D-printed tumor mold for tissue sampling

Interventions

3D-printed tumor mold for tissue sampling PROCEDURE

3D-printed tumor mold for tissue sampling

Study arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tampere University Hospital: lead
• Tampere University: collaborator
• Kuopio University Hospital: collaborator
• University of Eastern Finland: collaborator

Study Sites (1)

Tampere University Hospital

Tampere, Finland

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Otso Arponen, MD

CONTACT

+359 3 311 611; otso.arponen@tuni.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 21, 2026
• Study Start: May 31, 2024
• Primary Completion (Estimated): December 1, 2033
• Study Completion (Estimated): December 15, 2033
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)