Health Trials

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

ConditionsCancerTumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorTampere University Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 3D-printed tumor mold for tissue sampling

    Procedure/Surgery

    3D-printed tumor mold for tissue sampling

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Study armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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

Other outcomes

Sponsors and contacts

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Tampere University Hospital

Lead sponsor

Tampere University

Collaborator

Kuopio University Hospital

Collaborator

University of Eastern Finland

Collaborator

Source ClinicalTrials.gov
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