Gastroenteropancreatic Neuroendocrine TumorsPhase 2NETTER-PNCT04711135
Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs
A Phase 2 study testing Lutetium [177Lu] oxodotreotide/dotatate in people with Gastroenteropancreatic Neuroendocrine Tumors and Pheochromocytoma, run by Advanced Accelerator Applications at 7 sites in 5 countries.
Trial summary
This is a multicenter, open-label, single-arm study to evaluate the safety and dosimetry of Lutathera in adolescent patients 12 to <18 years old with somatostatin receptor positive GEP-NETs and PPGLs. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Gastroenteropancreatic Neuroendocrine Tumors, Pheochromocytoma, Paraganglioma
- What is being tested?
- Lutetium [177Lu] oxodotreotide/dotatate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 31 Aug 2022to 6 Feb 2034
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- GEP-NET cohort: presence of metastasized or locally advanced, inoperable (curative intent), histologically proven, G1 or G2 (Ki-67 index =< 20%), well differentiated GEP-NET.
- or PPGL cohort: presence of metastasized or locally advanced, inoperable (curative intent), histologically proven PPGL.
- Patients from 12 to < 18 years of age at the time of enrollment.
- Expression of somatostatin receptors confirmed by a somatostatin receptor imaging (SRI) modality within 3 months prior to enrollment, with tumor uptake observed in the target lesions more or equal to the normal liver uptake.
- Performance status as determined by Karnofsky score >= 50 or Lansky Play-Performance Scale score >= 50.
- Parent's ability to understand and the willingness to sign a written informed consent document for adolescents as determined by local regulations. Adolescents will sign assent along with parental/legal guardian consent or will co-sign consent with parent/legal guardian in accordance with local regulation, prior to participation in the study.
Who cannot join
- Laboratory parameters:
- Estimated creatinine clearance calculated by the Cockroft-Gault method < 70 mL/min
- Hb concentration <5.0 mmol/L (<8.0 g/dL); WBC <2x109/L; platelets <75x109/L.
- Total bilirubin >3 x ULN for age.
- Serum albumin <3.0 g/dL unless prothrombin time is within the normal range.
- Established or suspected pregnancy.
Show all 16Show fewer
- Breastfeeding female patients unless they accept to discontinue breastfeeding from the 1st dose until 3 months after the last administration of study drug.
- Female patients of child-bearing potential, unless they are using highly effective methods of contraception during treatment and for 6 months after the last dose of Lutathera.
- Sexually active male patients, unless they agree to remain abstinent or be willing to use effective methods of contraception.
- Patients for whom in the opinion of the investigator other therapeutic options are considered more appropriate than the therapy offered in the study, based on patient and disease characteristics.
- Current spontaneous urinary incontinence.
- Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years.
- Hypersensitivity to the study drug active substance or to any of the excipients.
- Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with the completion of the study.
- Patient with known incompatibility to CT Scans with I.V. contrast due to allergic reaction or renal insufficiency. If such a patient can be imaged with MRI, then the patient would not be excluded.
- Patients who received any investigational agent within the last 30 days.
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
United States3 sites
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229-3039
University of Kentucky
Lexington, Kentucky, 40536
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Poland1 site
Maria Sklodowska-Curie National Research Institute of Oncology
Gliwice
About this study
Official title: A Multicenter Open-label Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors, Pheochromocytoma and Paragangliomas (PPGL)
This is a multicenter, open-label, single-arm study to evaluate the safety and dosimetry of Lutathera in adolescent patients 12 to <18 years old with somatostatin receptor positive GEP-NETs and PPGLs. The study will enroll at least 8 patients in the GEP-NET cohort and as many adolescents with PPGL as possible in the exploratory PPGL cohort.
Read the detailed description
The study schedule for each patient consists of the screening period (up to 2 weeks) followed by the treatment period (4 treatment administrations at 8-week interval), and the follow-up period (10 years).
The treatment period will consist of 4 Lutathera treatments administered at 8-week intervals. Lutathera administration will occur on Week 1 Day 1 of each cycle. Each patient will receive a total of 4 doses of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8 weeks; cumulative dose: 29.6 GBq/800 mCi). An infusion of 2.5% Lysine - Arginine amino acid (AA) solution will be co-administered with each Lutathera dose for renal protection according to the approved Lutathera local prescribing information. An antiemetic will be administered prior to infusion of the AA solution for prevention of infusion-related nausea and vomiting.
The dosimetry and PK assessments will be performed during the first week after the 1st Lutathera dose, i.e. one time during the study treatment period for each patient. The dosimetry analysis will allow for estimation from the 1st Lutathera administration of the cumulative absorbed radiation dose from 4 Lutathera doses and also for taking a decision on the next dose levels. In the exceptional circumstances when dosimetry cannot be performed in a particular patient after the first Lutathera dose, it should be completed as soon as feasible upon a later dose. In order to minimize risk for each study subject, an accelerated analysis of dosimetry and safety data will be performed for each patient in the study, to enable the Investigator to take a decision for the subsequent Lutathera doses. The results of dosimetry assessments (imaging and blood dosimetry) will be provided to the investigators for their evaluation prior to administration of subsequent therapeutic cycles in each patient.
A total follow-up period of 10 years (120 months) after the last Lutathera dose will take place for each patient who received at least one dose of Lutathera. This follow-up period will be comprised of a short-term follow-up of 6 months to evaluate cumulative Lutathera toxicities, followed by a long-term follow up of another 114 months.
An external Data and Safety Monitoring Board (DSMB) will also operate in the study to evaluate accumulating safety and dosimetry data, to ensure the safety of adolescents enrolled in the study, and to provide recommendations to investigators as well as to the clinical team in charge of conducting the study.
- Being tested
- Lutetium [177Lu] oxodotreotide/dotatate
- Keywords
- GEP-NET, PPGL, adolescents, pediatric, Lutathera, Lutetium [177Lu] oxodotreotide, Lutetium Lu 177 dotatate, Peptide Receptor Radionuclide Therapy, PRRT
- Medical subject headings
- Pheochromocytoma, Paraganglioma, Gastro-enteropancreatic neuroendocrine tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutetium [177Lu] oxodotreotide/dotatateDrug
Also called Lutathera
Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
| Study group | Role | What they receive |
|---|---|---|
| GEP-NET and PPGL | Experimental | All eligible participants will receive Lutathera (7.4 GBq/200 mCi x 4 administrations every 8 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution. Receives: Drug: Lutetium [177Lu] oxodotreotide/dotatate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absorbed Radiation Doses in Target Organ
Absorbed radiation doses in target organ (e.g. kidney and bone marrow) was evaluated when all Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) and Pheochromocytoma and paraganglioma (PPGLs) as a pooled cohort patients had completed the 1st treatment of Lutathera and completed the dosimetry assessment.
Measured: Up to 8 days after the first Lutetium [Lu 177] dotatate dose
Incidence of Adverse Events (AEs) and Lab Toxicities After 1st Lutathera Administration
Safety in adolescents with SSTR-positive GEP-NETs and PPGLs as a pooled cohort was evaluated through the incidence of AEs and laboratory abnormalities after the first Lutathera dose.
Measured: during first cycle of Lutetium [Lu 177] dotatate treatment (Cycle = 56 days)
Secondary outcomes (6)
Incidence of Adverse Events (AEs) During Treatment and Short-term Follow-up
Cumulative safety of Lutathera in adolescents with SSTR-positive GEP-NETs and PPGLs as a pooled cohort was assessed through the incidence of adverse events (AEs) and laboratory toxicities until 6 months after the last Lutathera dose.
Measured: From first Lutetium [Lu 177] dotatate dose to 6 months after last dose, approx. 12 months
Incidence of Adverse Events (AEs) During the Long Term Follow-up
Long-term safety of Lutathera in adolescents with SSTR-positive GEP-NETs and PPGLs as a pooled cohort was evaluated through the incidence of AEs and laboratory abnormalities during the 5-year follow-up after the last Lutathera dose.
Measured: Up to 5 years after the last Lutetium [Lu 177] dotatate dose
Calculated Probability of Exceeding the Kidney and Bone Marrow External Beam Radiation Therapy (EBRT) Threshold
A comparative assessment of dosimetry for organs at risk specifically kidneys and bone marrow, was performed between adolescent patients with GEP-NETs and PPGLs as a pooled cohort and adult patients using the extrapolation model developed for the clinical study to confirm the probability of exceeding 29 Gy (kidneys) \& 2 Gy (bone marrow) thresholds.
Measured: After 4 cycles of 7.4 GBq/200 mCi; each cycle is 8+/-1 weeks
Pharmacokinetics (PK) Parameter: AUClast - Based on Blood Radioactivity Concentration Data
A comparative assessment of PK will be performed between Observed and Predicted adolescent patients with GEP-NETs and PPGLs as a pooled cohort and adult patients using the extrapolation model developed for the clinical study. The observed PK metrics were calculated using non-compartmental analysis (NCA), the predicted PK metrics were derived based on the adolescent population pharmacokinetics (popPK) model.
Measured: Up to 72 hours after the first Lutetium [Lu 177] dotatate dose
Pharmacokinetics (PK) Parameter: Cmax - Based on Blood Radioactivity Concentration Data
A comparative assessment of PK will be performed between Observed and Predicted adolescent patients with GEP-NETs and PPGLs as a pooled cohort and adult patients using the extrapolation model developed for the clinical study. The observed PK metrics were calculated using non-compartmental analysis (NCA), the predicted PK metrics were derived based on the adolescent population pharmacokinetics (popPK) model.
Measured: Up to 72 hours after the first Lutetium [Lu 177] dotatate dose
Pharmacokinetics (PK) Parameter: Tmax - Based on Blood Radioactivity Concentration Data
A comparative assessment of PK will be performed between Observed and Predicted adolescent patients with GEP-NETs and PPGLs as a pooled cohort and adult patients using the extrapolation model developed for the clinical study. The observed PK metrics were calculated using non-compartmental analysis (NCA), the predicted PK metrics were derived based on the adolescent population pharmacokinetics (popPK) model.
Measured: Up to 72 hours after the first Lutetium [Lu 177] dotatate dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start31 Aug 2022
- Primary completion12 Mar 2024
- Study completion6 Feb 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroenteropancreatic Neuroendocrine TumorsStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Accelerator Applications
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711135
- Sponsor's protocol ID
- CAAA601A32201
- Other IDs
- 2020-002951-39, EMEA-002950-PIP01-20, 2023-507444-37-00, 2023
- Acronym
- NETTER-P
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2020
- Last updated
- 12 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Publications
Gaze MN, Handkiewicz-Junak D, Hladun R, Laetsch TW, Sorge C, Sparks R, Wan S, Ceraulo A, Kluczewska-Galka A, Gamez-Cenzano C, States LJ, El Khouli R, Aimone P, Perraud K, Kollar G, Khanshan F, Blumenstein L, Brouri F, Giraudet AL. Safety and dosimetry of [177Lu]Lu-DOTA-TATE in adolescent patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours, or pheochromocytomas and paragangliomas: Primary analysis of the Phase II NETTER-P study. Eur J Nucl Med Mol Imaging. 2025 Sep;52(11):4001-4015. doi: 10.1007/s00259-025-07246-7. Epub 2025 Apr 8.
PubMed 40198358
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open-label Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors, Pheochromocytoma and Paragangliomas (PPGL)
- ClinicalTrials.gov ID
- NCT04711135
- Acronym / sponsor ID
- NETTER-P / CAAA601A32201
- Keywords
- GEP-NET, PPGL, adolescents, pediatric, Lutathera, Lutetium [177Lu] oxodotreotide, Lutetium Lu 177 dotatate, Peptide Receptor Radionuclide Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Advanced Accelerator ApplicationsIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 6 Feb 2034 (estimated)
- First posted
- 15 Jan 2021 (actual)
- Results
- Posted 27 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label, single-arm study to evaluate the safety and dosimetry of Lutathera in adolescent patients 12 to <18 years old with somatostatin receptor positive GEP-NETs and PPGLs. The study will enroll at least 8 patients in the GEP-NET cohort and as many adolescents with PPGL as possible in the exploratory PPGL cohort.
Detailed description
The study schedule for each patient consists of the screening period (up to 2 weeks) followed by the treatment period (4 treatment administrations at 8-week interval), and the follow-up period (10 years).
The treatment period will consist of 4 Lutathera treatments administered at 8-week intervals. Lutathera administration will occur on Week 1 Day 1 of each cycle. Each patient will receive a total of 4 doses of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8 weeks; cumulative dose: 29.6 GBq/800 mCi). An infusion of 2.5% Lysine - Arginine amino acid (AA) solution will be co-administered with each Lutathera dose for renal protection according to the approved Lutathera local prescribing information. An antiemetic will be administered prior to infusion of the AA solution for prevention of infusion-related nausea and vomiting.
The dosimetry and PK assessments will be performed during the first week after the 1st Lutathera dose, i.e. one time during the study treatment period for each patient. The dosimetry analysis will allow for estimation from the 1st Lutathera administration of the cumulative absorbed radiation dose from 4 Lutathera doses and also for taking a decision on the next dose levels. In the exceptional circumstances when dosimetry cannot be performed in a particular patient after the first Lutathera dose, it should be completed as soon as feasible upon a later dose. In order to minimize risk for each study subject, an accelerated analysis of dosimetry and safety data will be performed for each patient in the study, to enable the Investigator to take a decision for the subsequent Lutathera doses. The results of dosimetry assessments (imaging and blood dosimetry) will be provided to the investigators for their evaluation prior to administration of subsequent therapeutic cycles in each patient.
A total follow-up period of 10 years (120 months) after the last Lutathera dose will take place for each patient who received at least one dose of Lutathera. This follow-up period will be comprised of a short-term follow-up of 6 months to evaluate cumulative Lutathera toxicities, followed by a long-term follow up of another 114 months.
An external Data and Safety Monitoring Board (DSMB) will also operate in the study to evaluate accumulating safety and dosimetry data, to ensure the safety of adolescents enrolled in the study, and to provide recommendations to investigators as well as to the clinical team in charge of conducting the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GEP-NET and PPGL | Experimental | Drug: Lutetium [177Lu] oxodotreotide/dotatateAll eligible participants will receive Lutathera (7.4 GBq/200 mCi x 4 administrations every 8 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- GEP-NET cohort: presence of metastasized or locally advanced, inoperable (curative intent), histologically proven, G1 or G2 (Ki-67 index =< 20%), well differentiated GEP-NET.
- or PPGL cohort: presence of metastasized or locally advanced, inoperable (curative intent), histologically proven PPGL.
- Patients from 12 to < 18 years of age at the time of enrollment.
- Expression of somatostatin receptors confirmed by a somatostatin receptor imaging (SRI) modality within 3 months prior to enrollment, with tumor uptake observed in the target lesions more or equal to the normal liver uptake.
- Performance status as determined by Karnofsky score >= 50 or Lansky Play-Performance Scale score >= 50.
Key exclusion criteria (16 listed)
- Laboratory parameters:
- Established or suspected pregnancy.
- Breastfeeding female patients unless they accept to discontinue breastfeeding from the 1st dose until 3 months after the last administration of study drug.
- Female patients of child-bearing potential, unless they are using highly effective methods of contraception during treatment and for 6 months after the last dose of Lutathera.
- Sexually active male patients, unless they agree to remain abstinent or be willing to use effective methods of contraception.
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 |
|---|---|---|
| Lutetium [177Lu] oxodotreotide/dotatateAlso: LutatheraRadiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial) | Drug | GEP-NET and PPGL |
Primary outcome
Absorbed Radiation Doses in Target Organ
Time frame: Up to 8 days after the first Lutetium [Lu 177] dotatate dose
Absorbed radiation doses in target organ (e.g. kidney and bone marrow) was evaluated when all Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) and Pheochromocytoma and paraganglioma (PPGLs) as a pooled cohort patients had completed the 1st treatment of Lutathera and completed the dosimetry assessment.
Incidence of Adverse Events (AEs) and Lab Toxicities After 1st Lutathera Administration
Time frame: during first cycle of Lutetium [Lu 177] dotatate treatment (Cycle = 56 days)
Safety in adolescents with SSTR-positive GEP-NETs and PPGLs as a pooled cohort was evaluated through the incidence of AEs and laboratory abnormalities after the first Lutathera dose.
6 secondary outcomes
Incidence of Adverse Events (AEs) During Treatment and Short-term Follow-up
Time frame: From first Lutetium [Lu 177] dotatate dose to 6 months after last dose, approx. 12 months
Incidence of Adverse Events (AEs) During the Long Term Follow-up
Time frame: Up to 5 years after the last Lutetium [Lu 177] dotatate dose
Calculated Probability of Exceeding the Kidney and Bone Marrow External Beam Radiation Therapy (EBRT) Threshold
Time frame: After 4 cycles of 7.4 GBq/200 mCi; each cycle is 8+/-1 weeks
Pharmacokinetics (PK) Parameter: AUClast - Based on Blood Radioactivity Concentration Data
Time frame: Up to 72 hours after the first Lutetium [Lu 177] dotatate dose
Pharmacokinetics (PK) Parameter: Cmax - Based on Blood Radioactivity Concentration Data
Time frame: Up to 72 hours after the first Lutetium [Lu 177] dotatate dose
Pharmacokinetics (PK) Parameter: Tmax - Based on Blood Radioactivity Concentration Data
Time frame: Up to 72 hours after the first Lutetium [Lu 177] dotatate dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40198358Gaze MN, Handkiewicz-Junak D, Hladun R, Laetsch TW, Sorge C, Sparks R, Wan S, Ceraulo A, Kluczewska-Galka A, Gamez-Cenzano C, States LJ, El Khouli R, Aimone P, Perraud K, Kollar G, Khanshan F, Blumenstein L, Brouri F, Giraudet AL. Safety and dosimetry of [177Lu]Lu-DOTA-TATE in adolescent patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours, or pheochromocytomas and paragangliomas: Primary analysis of the Phase II NETTER-P study. Eur J Nucl Med Mol Imaging. 2025 Sep;52(11):4001-4015. doi: 10.1007/s00259-025-07246-7. Epub 2025 Apr 8.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lutetium [177Lu] oxodotreotide/dotatate in people with Gastroenteropancreatic Neuroendocrine Tumors and Pheochromocytoma, run by Advanced Accelerator Applications at 7 sites in 5 countries.
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 6 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, France, Poland, Spain, United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Absorbed Radiation Doses in Target Organ (time frame: Up to 8 days after the first Lutetium [Lu 177] dotatate dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04711135, which also lists 1 linked publication.
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 12 Feb 2026.