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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07778173
Acronym
DIRECT
Enrollment
30
Registered
2026-08-21
Start date
2024-05-31
Completion date
2033-12-15
Last updated
2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Tumor

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.

Interventions

PROCEDURE3D-printed tumor mold for tissue sampling

3D-printed tumor mold for tissue sampling

Sponsors

Tampere University Hospital
Lead SponsorOTHER
Tampere University
CollaboratorOTHER
Kuopio University Hospital
CollaboratorOTHER
University of Eastern Finland
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
2. Histopathological evaluationAfter 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

Secondary

MeasureTime frameDescription
Biomarker evaluation from the samples obtained using 3D-moldAfter the surgery throughout the study period and upon the completion of study recruitment within 3 monthsRate of presentation of biomarkers evaluated from the samples obtained using 3D-molds

Countries

Finland

Contacts

CONTACTOtso Arponen, MD
otso.arponen@tuni.fi+359 3 311 611

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026