Clinical trial · Interventional
Three-Dimensional Molds Based on Radiological imagEs in Patients With Cancer: the DIRECT Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D-printed tumor mold for tissue sampling | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study arm
- interventionNames
- Procedure: 3D-printed tumor mold for tissue sampling
Primary outcomes (1)
- measure
- 2. Histopathological evaluation
- timeFrame
- After the surgery upon review of the histopathological sample (within 3 months of the operation)
- description
- Rate of malignant/benign and higher/lower grade tumor tissue in the samples obtained using 3D-molds
Secondary outcomes (1)
- measure
- Biomarker evaluation from the samples obtained using 3D-mold
- timeFrame
- After the surgery throughout the study period and upon the completion of study recruitment within 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available