CancerDIRECTNCT07778173
Three-Dimensional Molds Based on Radiological imagEs in Patients With Cancer: the DIRECT Trial
A study testing 3D-printed tumor mold for tissue sampling in people with Cancer and Tumor, run by Tampere University Hospital at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Any age
- What is being tested?
- 3D-printed tumor mold for tissue sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 31 May 2024to 15 Dec 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Tampere University Hospital
Tampere
Otso Arponen, MD, +358 3 311 611, otso.arponen@tuni.fi
About this study
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.
- Being tested
- 3D-printed tumor mold for tissue sampling
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-printed tumor mold for tissue samplingProcedure or surgery
3D-printed tumor mold for tissue sampling
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Not described Receives: Procedure: 3D-printed tumor mold for tissue sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
2. Histopathological evaluation
Rate of malignant/benign and higher/lower grade tumor tissue in the samples obtained using 3D-molds
Measured: 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
Measured: After the surgery throughout the study period and upon the completion of study recruitment within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start31 May 2024
- Primary completionDec 2033 (estimated)
- Study completion15 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, Kuopio University Hospital, University of Eastern Finland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778173
- Sponsor's protocol ID
- R23084
- Acronym
- DIRECT
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-Dimensional Molds Based on Radiological imagEs in Patients With Cancer: the DIRECT Trial
- ClinicalTrials.gov ID
- NCT07778173
- Acronym / sponsor ID
- DIRECT / R23084
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University, Kuopio University Hospital, University of Eastern Finland
- Study start
- 31 May 2024 (actual)
- Primary completion
- Dec 2033 (estimated)
- Study completion
- 15 Dec 2033 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Procedure: 3D-printed tumor mold for tissue sampling |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D-printed tumor mold for tissue sampling3D-printed tumor mold for tissue sampling | Procedure or surgery | Study arm |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruiting
Using e-Technologies to Maximize Physical Activity After Cancer Treatment
Cancer
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Pharmacogenetic Determinants Of Treatment Response In Children
All Malignancies, Children Being Treated for Catastrophic Illness
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-printed tumor mold for tissue sampling in people with Cancer and Tumor, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Otso Arponen, MD (+359 3 311 611, otso.arponen@tuni.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2. Histopathological evaluation (time frame: After the surgery upon review of the histopathological sample (within 3 months of the operation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.