TriangleNCT04711135 · STUDY IN CONTEXT
Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
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.
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.
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.
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.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-neuroendocrine-tumors
- nct id
- NCT04711135
- trial label
- Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-neuroendocrine-tumors
- nct id
- NCT04711135
- outcome key
- om-0000
- source section id
- NCT04711135-om-0000
- source outcome index
- 0
- endpoint
- Absorbed Radiation Doses in Target Organ
- endpoint definition
- 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.
- time origin
- Up to 8 days after the first Lutetium [Lu 177] dotatate dose
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Dosimetry Analysis Set (DAS): The DAS consisted of all participants who had at least one valid (i.e., not flagged for exclusion by the dosimetrist) dosimetry measurement.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-neuroendocrine-tumors
- nct id
- NCT04711135
- outcome key
- om-0001
- source section id
- NCT04711135-om-0001
- source outcome index
- 1
- endpoint
- Incidence of Adverse Events (AEs) and Lab Toxicities After 1st Lutathera Administration
- endpoint definition
- 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.
- time origin
- during first cycle of Lutetium [Lu 177] dotatate treatment (Cycle = 56 days)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety Set: The Safety Set included all participants that received at least one dose of Lutathera.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-neuroendocrine-tumors
- nct id
- NCT04711135
- outcome key
- om-0002
- source section id
- NCT04711135-om-0002
- source outcome index
- 2
- endpoint
- Incidence of Adverse Events (AEs) During Treatment and Short-term Follow-up
- endpoint definition
- 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.
- time origin
- From first Lutetium [Lu 177] dotatate dose to 6 months after last dose, approx. 12 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety Set: The Safety Set included all participants that received at least one dose of Lutathera.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-neuroendocrine-tumors
- nct id
- NCT04711135
- outcome key
- om-0003
- source section id
- NCT04711135-om-0003
- source outcome index
- 3
- endpoint
- Incidence of Adverse Events (AEs) During the Long Term Follow-up
- endpoint definition
- 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.
- time origin
- Up to 5 years after the last Lutetium [Lu 177] dotatate dose
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-neuroendocrine-tumors
- nct id
- NCT04711135
- outcome key
- om-0004
- source section id
- NCT04711135-om-0004
- source outcome index
- 4
- endpoint
- Calculated Probability of Exceeding the Kidney and Bone Marrow External Beam Radiation Therapy (EBRT) Threshold
- endpoint definition
- 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.
- time origin
- After 4 cycles of 7.4 GBq/200 mCi; each cycle is 8+/-1 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Dosimetry Analysis Set (DAS) consisted of all participants who had at least one valid dosimetry measurement. Original NETTER-P protocol intended to conduct separate analyses for the GEP-NET and the PPGL populations. However, the protocol was amended to allow combined analyses for dosimetry across the two patient indications. The number of patients was equal 10, since data from one patient was excluded from the dosimetry modeling analysis, due to technical issues during image acquisitions.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-neuroendocrine-tumors
- nct id
- NCT04711135
- outcome key
- om-0005
- source section id
- NCT04711135-om-0005
- source outcome index
- 5
- endpoint
- Pharmacokinetics (PK) Parameter: AUClast - Based on Blood Radioactivity Concentration Data
- endpoint definition
- 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.
- time origin
- Up to 72 hours after the first Lutetium [Lu 177] dotatate dose
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The PK Analysis Set (PKAS) consisted of all participants who had at least one valid (i.e., not flagged for exclusion) PK measurement. Original NETTER-P protocol intended to conduct separate analyses for the GEP-NET and the PPGL populations. However, the protocol was amended to allow combined analyses for PK across the two patient indications.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-neuroendocrine-tumors
- nct id
- NCT04711135
- outcome key
- om-0000
- arm key
- OG000
- arm label
- GEP-NET
- regimen
- All eligible participants with Gastroenteropancreatic neuroendocrine tumor (GEP-NET) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04711135-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-neuroendocrine-tumors
- nct id
- NCT04711135
- outcome key
- om-0000
- arm key
- OG001
- arm label
- PPGL
- regimen
- All eligible participants with Pheochromocytoma and paraganglioma (PPGL) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04711135-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-neuroendocrine-tumors
- nct id
- NCT04711135
- outcome key
- om-0001
- arm key
- OG000
- arm label
- GEP-NET
- regimen
- All eligible participants with Gastroenteropancreatic neuroendocrine tumor (GEP-NET) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04711135-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-neuroendocrine-tumors
- nct id
- NCT04711135
- outcome key
- om-0001
- arm key
- OG001
- arm label
- PPGL
- regimen
- All eligible participants with Pheochromocytoma and paraganglioma (PPGL) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04711135-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-neuroendocrine-tumors
- nct id
- NCT04711135
- outcome key
- om-0002
- arm key
- OG000
- arm label
- GEP-NET
- regimen
- All eligible participants with Gastroenteropancreatic neuroendocrine tumor (GEP-NET) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04711135-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-neuroendocrine-tumors
- nct id
- NCT04711135
- outcome key
- om-0002
- arm key
- OG001
- arm label
- PPGL
- regimen
- All eligible participants with Pheochromocytoma and paraganglioma (PPGL) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04711135-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-neuroendocrine-tumors
- nct id
- NCT04711135
- outcome key
- om-0004
- arm key
- OG000
- arm label
- GEP-NET and PPGL
- regimen
- All eligible participants with Gastroenteropancreatic neuroendocrine tumor (GEP-NET) and Pheochromocytoma and paraganglioma (PPGL) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04711135-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-neuroendocrine-tumors
- nct id
- NCT04711135
- outcome key
- om-0005
- arm key
- OG000
- arm label
- GEP-NET and PPGL
- regimen
- All eligible participants with Gastroenteropancreatic neuroendocrine tumor (GEP-NET) and Pheochromocytoma and paraganglioma (PPGL) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04711135-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-neuroendocrine-tumors
- nct id
- NCT04711135
- harm key
- EG000
- source section id
- NCT04711135-ae
- event group key
- EG000
- event group label
- GEP-NET
- serious affected
- 1
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 5
- collection period
- AEs & on-treatment deaths were collected from the first dose of study treatment up to data cut-off date of 12-Mar-2024, approx. 19 months from the FPFV.
- event definition
- Any sign or symptom that occurs during the conduct of the trial.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-neuroendocrine-tumors
- nct id
- NCT04711135
- harm key
- EG001
- source section id
- NCT04711135-ae
- event group key
- EG001
- event group label
- PPGL
- serious affected
- 1
- serious at risk
- 7
- other affected
- 7
- other at risk
- 7
- frequency threshold
- 5
- collection period
- AEs & on-treatment deaths were collected from the first dose of study treatment up to data cut-off date of 12-Mar-2024, approx. 19 months from the FPFV.
- event definition
- Any sign or symptom that occurs during the conduct of the trial.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-neuroendocrine-tumors
- nct id
- NCT04711135
- harm key
- EG002
- source section id
- NCT04711135-ae
- event group key
- EG002
- event group label
- Total
- serious affected
- 2
- serious at risk
- 11
- other affected
- 11
- other at risk
- 11
- frequency threshold
- 5
- collection period
- AEs & on-treatment deaths were collected from the first dose of study treatment up to data cut-off date of 12-Mar-2024, approx. 19 months from the FPFV.
- event definition
- Any sign or symptom that occurs during the conduct of the trial.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice