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

Tampere University Hospital30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cancer Tumor

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

2. Histopathological evaluation

Rate of malignant/benign and higher/lower grade tumor tissue in the samples obtained using 3D-molds

Time frame: After the surgery upon review of the histopathological sample (within 3 months of the operation)

Secondary Outcomes

Biomarker evaluation from the samples obtained using 3D-mold

Rate of presentation of biomarkers evaluated from the samples obtained using 3D-molds

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