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NCT Number: NCT07778173

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

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.

Recruiting

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Key information

Conditions

Cancer Neoplasms Tumor

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3D-printed tumor mold for tissue sampling

Procedure

3D-printed tumor mold for tissue sampling

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Otso Arponen, MD

CONTACT

[email protected]

+359 3 311 611

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Kuopio University Hospital
  • Tampere University
  • University of Eastern Finland

Registry information

Acronym: DIRECT

Important dates

Study start
2024
Primary completion
2033
Study completion
2033
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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