Neuroendocrine TumorsPhase 2/3ATSANCT06855095
Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial
A Phase 2/3 study testing Somatostatin analog in people with Neuroendocrine Tumors and Neuroendocrine Tumor Grade 1, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
According to current guidelines, patients have to withhalt long-acting somatostatin analogues (LA-SSA) for 4-6 weeks prior to every 177Lutetium-DOTATATE administration. The primary objective of the study is to investigate the effect of LA-SSA on the absorbed dose in tumor lesions during PRRT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Neuroendocrine Tumor Grade 1, Neuroendocrine Tumor Grade 2
- What is being tested?
- Somatostatin analog
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Jun 2024to 1 Mar 2027
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Able to provide spoken and written informed consent for the trial;
- Histopathological confirmed neuroendocrine tumor;
- Fulfill the clinical criteria for PRRT;
- At least one soft tissue lesion > 2 cm;
- Aimed administered activity of 7400 MBq;
- ECOG score (performance status) 0-2.
Who cannot join
- Not possible to discontinue LA-SSA for 4-6 weeks;
- Use of short-acting SSAs;
- Pregnancy and lactating female patients;
- Inability to comply to the study procedures;
- Factors that might affect the biodistribution (for example, indication for furosemide directly after PRRT infusion, limited fluid intake, any renal catheters, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Antoni van Leeuwenhoek
Amsterdam
Stokkel, +31205129111, ev.schouten@nki.nl
About this study
According to current guidelines, patients have to withhalt long-acting somatostatin analogues (LA-SSA) for 4-6 weeks prior to every 177Lutetium-DOTATATE administration. The primary objective of the study is to investigate the effect of LA-SSA on the absorbed dose in tumor lesions during PRRT.
Read the detailed description
The study population includes all patients aged over 18 with a neuroendocrine tumor grade I and II and a clinical indication for PRRT. Patients treated for at least three months with LA-SSA are randomized over two interventional arms: one arm where patients discontinue LA-SSA 4-6 weeks before the first PRRT treatment and one arm where patients continue LA-SSA treatment and receive the first PRRT administration within one week after the most recent LA-SSA injection. Patients in the control arm who have not been treated with LA-SSA in the last three months will start PRRT according to standard local protocol.
- Conditions
- Neuroendocrine Tumors, Neuroendocrine Tumor Grade 1, Neuroendocrine Tumor Grade 2, Neuroendocrine Neoplasm
- Being tested
- Somatostatin analog
- Keywords
- Peptide Receptor Radionuclide Therapy, PRRT, Lutetium, DOTATATE
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatostatin analogDrug
Timing of LA-SSA injection prior to PRRT (either 4-6 weeks or 1-7 days).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | In this arm, patients without any LA-SSA treatment for at least 3 months prior to PRRT are included. |
| 2A - LA-SSA injection 4-6 weeks before PRRT | Active comparator | In this arm, patients on LA-SSA treatment for at least 3 months prior to PRRT are included and will receive the last LA-SSA injection 4-6 weeks before PRRT. Receives: Drug: Somatostatin analog |
| 2B - LA-SSA injection 1-7 days before PRRT | Experimental | In this arm, patients on LA-SSA treatment for at least 3 months prior to PRRT are included and will receive the last LA-SSA injection 4-6 weeks before PRRT. Receives: Drug: Somatostatin analog |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of continued LA-SSA use on the absorbed dose in tumor lesions during PRRT.
Measured: SPECT/CT after 4h, 24h, and 5-7 days post-injection
Secondary outcomes (3)
Effect of continued LA-SSA use on the absorbed dose in normal tissues during PRRT.
Measured: SPECT/CT after 4h, 24h, and 5-7 days post-injection and blood samples at 2h, 4h, 24h and 5-7 days post-injection
Effect of continued LA-SSA use on the tumor-to-background ratio.
Measured: SPECT/CT after 4h, 24h, and 5-7 days post-injection
Effect of continued LA-SSA use on population pharmacokinetic parameters of [177Lu]Lu-HA-DOTATATE.
Measured: Blood samples at 2h, 4h, 24h and 5-7 days post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start25 Jun 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
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 The Netherlands Cancer InstituteThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Neuroendocrine Tumor Research Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855095
- Sponsor's protocol ID
- N23PRR
- Acronym
- ATSA
- Status last verified
- Feb 2025
- First submitted
- 25 Oct 2023
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial
- ClinicalTrials.gov ID
- NCT06855095
- Acronym / sponsor ID
- ATSA / N23PRR
- Conditions
- Neuroendocrine Tumors, Neuroendocrine Tumor Grade 1, Neuroendocrine Tumor Grade 2, Neuroendocrine Neoplasm
- Keywords
- Peptide Receptor Radionuclide Therapy, PRRT, Lutetium, DOTATATE
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Neuroendocrine Tumor Research Foundation
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 3 Mar 2025 (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.
According to current guidelines, patients have to withhalt long-acting somatostatin analogues (LA-SSA) for 4-6 weeks prior to every 177Lutetium-DOTATATE administration. The primary objective of the study is to investigate the effect of LA-SSA on the absorbed dose in tumor lesions during PRRT.
Detailed description
The study population includes all patients aged over 18 with a neuroendocrine tumor grade I and II and a clinical indication for PRRT. Patients treated for at least three months with LA-SSA are randomized over two interventional arms: one arm where patients discontinue LA-SSA 4-6 weeks before the first PRRT treatment and one arm where patients continue LA-SSA treatment and receive the first PRRT administration within one week after the most recent LA-SSA injection. Patients in the control arm who have not been treated with LA-SSA in the last three months will start PRRT according to standard local protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –In this arm, patients without any LA-SSA treatment for at least 3 months prior to PRRT are included. |
| 2A - LA-SSA injection 4-6 weeks before PRRT | Active comparator | Drug: Somatostatin analogIn this arm, patients on LA-SSA treatment for at least 3 months prior to PRRT are included and will receive the last LA-SSA injection 4-6 weeks before PRRT. |
| 2B - LA-SSA injection 1-7 days before PRRT | Experimental | Drug: Somatostatin analogIn this arm, patients on LA-SSA treatment for at least 3 months prior to PRRT are included and will receive the last LA-SSA injection 4-6 weeks before PRRT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years;
- Able to provide spoken and written informed consent for the trial;
- Histopathological confirmed neuroendocrine tumor;
- Fulfill the clinical criteria for PRRT;
- At least one soft tissue lesion > 2 cm;
Key exclusion criteria (5 listed)
- Not possible to discontinue LA-SSA for 4-6 weeks;
- Use of short-acting SSAs;
- Pregnancy and lactating female patients;
- Inability to comply to the study procedures;
- Factors that might affect the biodistribution (for example, indication for furosemide directly after PRRT infusion, limited fluid intake, any renal catheters, etc.).
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 |
|---|---|---|
| Somatostatin analogTiming of LA-SSA injection prior to PRRT (either 4-6 weeks or 1-7 days). | Drug | 2A - LA-SSA injection 4-6 weeks before PRRT, 2B - LA-SSA injection 1-7 days before PRRT |
Primary outcome
Effect of continued LA-SSA use on the absorbed dose in tumor lesions during PRRT.
Time frame: SPECT/CT after 4h, 24h, and 5-7 days post-injection
3 secondary outcomes
Effect of continued LA-SSA use on the absorbed dose in normal tissues during PRRT.
Time frame: SPECT/CT after 4h, 24h, and 5-7 days post-injection and blood samples at 2h, 4h, 24h and 5-7 days post-injection
Effect of continued LA-SSA use on the tumor-to-background ratio.
Time frame: SPECT/CT after 4h, 24h, and 5-7 days post-injection
Effect of continued LA-SSA use on population pharmacokinetic parameters of [177Lu]Lu-HA-DOTATATE.
Time frame: Blood samples at 2h, 4h, 24h and 5-7 days post-injection
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 3 Mar 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Somatostatin analog in people with Neuroendocrine Tumors and Neuroendocrine Tumor Grade 1, run by The Netherlands Cancer Institute at 1 site in Netherlands.
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 7 inclusion and 5 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 3 Mar 2025. 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 Netherlands. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of continued LA-SSA use on the absorbed dose in tumor lesions during PRRT. (time frame: SPECT/CT after 4h, 24h, and 5-7 days post-injection). 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 3 Mar 2025.