Neuroendocrine TumorsPhase 1NCT06122610
Using Novel Imaging to More Safely Treat Neuroendocrine Tumors
A Phase 1 study testing Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT), Photon Emission Tomography / CT (PET/CT) and 64Cu-Dotatate in people with Neuroendocrine Tumors and Somatostatin Receptor-positive Neuroendocrine Tumor, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The goal of this research is to determine if DetectnetTM PET/CT can be used to make Lutathera therapy safer for patients with neuroendocrine cancer. Participants will: Complete two phases involving 6 visits Undergo additional research PET/CT, and possibly SPECT/CT scans Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Somatostatin Receptor-positive Neuroendocrine Tumor
- What is being tested?
- Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT), Photon Emission Tomography / CT (PET/CT) and 64Cu-Dotatate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2025to 31 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates for 177Lu-DOTATATE (Lutathera) treatment for somatostatin receptor-positive neuroendocrine tumor
Who cannot join
- Unable to lie flat during or tolerate PET/CT or SPECT/CT
- Known incompatibility to CT. SPECT, or PET scans
- Unlikely to comply with study procedures, restrictions and requirements and judged by the investigator that the participant is not suitable for participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53705
About this study
Official title: Dosimetry-Guided 177Lu-DOTATATE Treatment Planning Using 64Cu-DOTATATE as a Surrogate
The goal of this research is to determine if DetectnetTM PET/CT can be used to make Lutathera therapy safer for patients with neuroendocrine cancer.
Participants will:
- Complete two phases involving 6 visits
- Undergo additional research PET/CT, and possibly SPECT/CT scans
Read the detailed description
The goal of this research study is to determine if DetectnetTM PET/CT scanning over several days can be used to deliver Lutathera in a safer manner.
In this research, participants will be asked to complete a screening phase and possibly a dosimetry phase. The screening phase will require 2 visits. The dosimetry phase will also require 3 research visits.
- Being tested
- Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT), Photon Emission Tomography / CT (PET/CT), 64Cu-Dotatate, 177Lu-Dotatate
- Keywords
- neuroendocrine tumors
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)Device
SPECT/CT will be performed after first cycle of Lutathera® treatment
Photon Emission Tomography / CT (PET/CT)Device
PET/CT will be performed after 64Cu-DOTATATE and Lutathera® treatment
64Cu-DotatateDrug
Also called Detectnet
Standard of care administration of radioactive drug for PET/CT
177Lu-DotatateDrug
Also called Lutathera®
Standard of care administration of radioactive drug for PET/CT and SPECT/CT
| Study group | Role | What they receive |
|---|---|---|
| Participants treated with Lutathera | Experimental | Not described Receives: Device: Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT); Device: Photon Emission Tomography / CT (PET/CT); Drug: 64Cu-Dotatate; Drug: 177Lu-Dotatate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare pre-therapy and post-therapy voxel-based dosimetry estimates
Absorbed doses to organs will be estimated using radiation dosimetry methods based on both multi-timepoint PET and multi-timepoint SPECT imaging. Mean dose estimates in units of Gy to the index tumor(s) and dose limiting organs (kidneys and bone marrow) will be compared between PET-based dosimetry and SPECT-based dosimetry. Using SPECT-based dosimetry as the gold standard truth, Bland-Altman analysis will be performed for each organ/tumor to compare PET-based dose estimates to SPECT-based estimates. Mean bias and 95% confidence intervals will be calculated.
Measured: Baseline and 120 hours post-dose
Secondary outcomes (3)
Absorbed radiation doses
Absorbed radiation doses from 177Lu-DOTATATE in organs will be summarized with descriptive statistics.
Measured: 1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose
Absorbed radiation doses of 64Cu-DOTATATE
Absorbed radiation doses of 177Lu-DOTATATE in organs using 64Cu-DOTATATE as an imagining surrogate will be summarized with descriptive statistics.
Measured: 1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose
Compare 3D voxel-based versus model based dosimetry in participants receiving 177Lu_DOTATATE
Absorbed doses to organs will be estimated using radiation dosimetry methods based on multi-timepoint SPECT imaging. Mean dose estimates in units of Gy to the index tumor(s) and dose limiting organs (kidneys and bone marrow) will be compared between 3D voxel-based and model-based dosimetry methods. Using 3D voxel-based dosimetry as the gold standard truth, Bland-Altman analysis will be performed for each organ/tumor to compare 3D voxel-based to model-based methods. Mean bias and 95% confidence intervals will be calculated.
Measured: Baseline and 120 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start7 Mar 2025
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Changhee Lee, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122610
- Sponsor's protocol ID
- 2023-0121
- Other IDs
- Protocol Version 4/7/2026, SMPH/RADIOLOGY/RADIOLOGY
- Status last verified
- Jun 2026
- First submitted
- 2 Nov 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosimetry-Guided 177Lu-DOTATATE Treatment Planning Using 64Cu-DOTATATE as a Surrogate
- ClinicalTrials.gov ID
- NCT06122610
- Acronym / sponsor ID
- 2023-0121
- Keywords
- neuroendocrine tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 8 Nov 2023 (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.
The goal of this research is to determine if DetectnetTM PET/CT can be used to make Lutathera therapy safer for patients with neuroendocrine cancer.
Participants will:
- Complete two phases involving 6 visits
- Undergo additional research PET/CT, and possibly SPECT/CT scans
Detailed description
The goal of this research study is to determine if DetectnetTM PET/CT scanning over several days can be used to deliver Lutathera in a safer manner.
In this research, participants will be asked to complete a screening phase and possibly a dosimetry phase. The screening phase will require 2 visits. The dosimetry phase will also require 3 research visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants treated with Lutathera | Experimental | Device: Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT), Device: Photon Emission Tomography / CT (PET/CT), Drug: 64Cu-Dotatate, Drug: 177Lu-Dotatate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Candidates for 177Lu-DOTATATE (Lutathera) treatment for somatostatin receptor-positive neuroendocrine tumor
Key exclusion criteria (3 listed)
- Unable to lie flat during or tolerate PET/CT or SPECT/CT
- Known incompatibility to CT. SPECT, or PET scans
- Unlikely to comply with study procedures, restrictions and requirements and judged by the investigator that the participant is not suitable for participation in the study
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 |
|---|---|---|
| Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)SPECT/CT will be performed after first cycle of Lutathera® treatment | Device | Participants treated with Lutathera |
| Photon Emission Tomography / CT (PET/CT)PET/CT will be performed after 64Cu-DOTATATE and Lutathera® treatment | Device | Participants treated with Lutathera |
| 64Cu-DotatateAlso: DetectnetStandard of care administration of radioactive drug for PET/CT | Drug | Participants treated with Lutathera |
| 177Lu-DotatateAlso: Lutathera®Standard of care administration of radioactive drug for PET/CT and SPECT/CT | Drug | Participants treated with Lutathera |
Primary outcome
Compare pre-therapy and post-therapy voxel-based dosimetry estimates
Time frame: Baseline and 120 hours post-dose
Absorbed doses to organs will be estimated using radiation dosimetry methods based on both multi-timepoint PET and multi-timepoint SPECT imaging. Mean dose estimates in units of Gy to the index tumor(s) and dose limiting organs (kidneys and bone marrow) will be compared between PET-based dosimetry and SPECT-based dosimetry. Using SPECT-based dosimetry as the gold standard truth, Bland-Altman analysis will be performed for each organ/tumor to compare PET-based dose estimates to SPECT-based estimates. Mean bias and 95% confidence intervals will be calculated.
3 secondary outcomes
Absorbed radiation doses
Time frame: 1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose
Absorbed radiation doses of 64Cu-DOTATATE
Time frame: 1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose
Compare 3D voxel-based versus model based dosimetry in participants receiving 177Lu_DOTATATE
Time frame: Baseline and 120 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Changhee Lee, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT), Photon Emission Tomography / CT (PET/CT) and 64Cu-Dotatate in people with Neuroendocrine Tumors and Somatostatin Receptor-positive Neuroendocrine Tumor, run by University of Wisconsin, Madison at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 23 Jun 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare pre-therapy and post-therapy voxel-based dosimetry estimates (time frame: Baseline and 120 hours post-dose). 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 23 Jun 2026.