Trial · NCT04711135

Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs

NCT04711135, Phase 2, Active not recruiting, Advanced Accelerator Applications; results first posted 2024-11-27

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs. Trials, record NCT04711135. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04711135

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs
NCT number: NCT04711135
Status: Active not recruiting
Phases: Phase 2
Enrollment: 11 participants, actual
Lead sponsor: Advanced Accelerator Applications
Conditions: Gastroenteropancreatic Neuroendocrine Tumors, Pheochromocytoma, Paraganglioma
Interventions: Lutetium [177Lu] oxodotreotide/dotatate
First posted: 2021-01-15
Last updated: 2026-02-12
Other registries' IDs: eudract:2020-002951-39
Results first posted: 2024-11-27

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Absorbed Radiation Doses in Target Organ	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.
Primary	Incidence of Adverse Events (AEs) and Lab Toxicities After 1st Lutathera Administration	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.
Secondary	Incidence of Adverse Events (AEs) During Treatment and Short-term Follow-up	From first Lutetium [Lu 177] dotatate dose to 6 months after last dose, approx. 12 months	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.
Secondary	Incidence of Adverse Events (AEs) During the Long Term Follow-up	Up to 5 years after the last Lutetium [Lu 177] dotatate 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.
Secondary	Calculated Probability of Exceeding the Kidney and Bone Marrow External Beam Radiation Therapy (EBRT) Threshold	After 4 cycles of 7.4 GBq/200 mCi; each cycle is 8+/-1 weeks	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.
Secondary	Pharmacokinetics (PK) Parameter: AUClast - Based on Blood Radioactivity Concentration Data	Up to 72 hours after the first Lutetium [Lu 177] dotatate dose	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.
Secondary	Pharmacokinetics (PK) Parameter: Cmax - Based on Blood Radioactivity Concentration Data	Up to 72 hours after the first Lutetium [Lu 177] dotatate dose	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.
Secondary	Pharmacokinetics (PK) Parameter: Tmax - Based on Blood Radioactivity Concentration Data	Up to 72 hours after the first Lutetium [Lu 177] dotatate dose	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.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Absorbed Radiation Doses in Target Organ	Up to 8 days after the first Lutetium [Lu 177] dotatate dose	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.	Gy/GBq	MEAN
PRIMARY	Incidence of Adverse Events (AEs) and Lab Toxicities After 1st Lutathera Administration	during first cycle of Lutetium [Lu 177] dotatate treatment (Cycle = 56 days)	Safety Set: The Safety Set included all participants that received at least one dose of Lutathera.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Incidence of Adverse Events (AEs) During Treatment and Short-term Follow-up	From first Lutetium [Lu 177] dotatate dose to 6 months after last dose, approx. 12 months	Safety Set: The Safety Set included all participants that received at least one dose of Lutathera.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Incidence of Adverse Events (AEs) During the Long Term Follow-up	Up to 5 years after the last Lutetium [Lu 177] dotatate dose
SECONDARY	Calculated Probability of Exceeding the Kidney and Bone Marrow External Beam Radiation Therapy (EBRT) Threshold	After 4 cycles of 7.4 GBq/200 mCi; each cycle is 8+/-1 weeks	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.	probability	NUMBER
SECONDARY	Pharmacokinetics (PK) Parameter: AUClast - Based on Blood Radioactivity Concentration Data	Up to 72 hours after the first Lutetium [Lu 177] dotatate dose	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.	ng.h/mL	GEOMETRIC_MEAN
SECONDARY	Pharmacokinetics (PK) Parameter: Cmax - Based on Blood Radioactivity Concentration Data	Up to 72 hours after the first Lutetium [Lu 177] dotatate dose	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.	ng/mL	GEOMETRIC_MEAN
SECONDARY	Pharmacokinetics (PK) Parameter: Tmax - Based on Blood Radioactivity Concentration Data	Up to 72 hours after the first Lutetium [Lu 177] dotatate dose	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.	hr	MEDIAN

Source ClinicalTrials.gov

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Absorbed Radiation Doses in Target Organ	GEP-NET	Kidney	0.71	Standard Deviation 0.25	Gy/GBq
Absorbed Radiation Doses in Target Organ	PPGL	Kidney	0.82	Standard Deviation 0.32	Gy/GBq
Absorbed Radiation Doses in Target Organ	GEP-NET	Pituitary	1.2	Standard Deviation 0.43	Gy/GBq
Absorbed Radiation Doses in Target Organ	PPGL	Pituitary	1.0	Standard Deviation 0.45	Gy/GBq
Absorbed Radiation Doses in Target Organ	GEP-NET	Red Marrow (Blood)	0.024	Standard Deviation 0.0035	Gy/GBq
Absorbed Radiation Doses in Target Organ	PPGL	Red Marrow (Blood)	0.028	Standard Deviation 0.0052	Gy/GBq
Absorbed Radiation Doses in Target Organ	GEP-NET	Red Marrow (Image)	0.043	Standard Deviation 0.018	Gy/GBq
Absorbed Radiation Doses in Target Organ	PPGL	Red Marrow (Image)	0.067	Standard Deviation 0.028	Gy/GBq
Absorbed Radiation Doses in Target Organ	GEP-NET	Spleen	0.63	Standard Deviation 0.39	Gy/GBq
Absorbed Radiation Doses in Target Organ	PPGL	Spleen	0.82	Standard Deviation 0.17	Gy/GBq

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	GEP-NET	4
Overall Study	STARTED	PPGL	7
Overall Study	Ongoing treatment	GEP-NET	0
Overall Study	Ongoing treatment	PPGL	1
Overall Study	Entered short term follow-up	GEP-NET	4
Overall Study	Entered short term follow-up	PPGL	5
Overall Study	Entered long term follow-up	GEP-NET	1
Overall Study	Entered long term follow-up	PPGL	3
Overall Study	COMPLETED	GEP-NET	4
Overall Study	COMPLETED	PPGL	5

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events189

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	GEP-NET	2	4
other	Anaemia	Blood and lymphatic system disorders	PPGL	2	7
other	Anaemia	Blood and lymphatic system disorders	Total	4	11
other	Leukopenia	Blood and lymphatic system disorders	GEP-NET	0	4
other	Leukopenia	Blood and lymphatic system disorders	PPGL	1	7
other	Leukopenia	Blood and lymphatic system disorders	Total	1	11
other	Lymphopenia	Blood and lymphatic system disorders	GEP-NET	2	4
other	Lymphopenia	Blood and lymphatic system disorders	PPGL	2	7
other	Lymphopenia	Blood and lymphatic system disorders	Total	4	11
other	Neutropenia	Blood and lymphatic system disorders	GEP-NET	1	4

1 to 10 of 189Source ClinicalTrials.gov

See all 189 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	GEP-NET	0	4
Total, all-cause mortality	PPGL	0	7
Total, all-cause mortality	Total	0	11
Total, other adverse events	GEP-NET	4	4
Total, other adverse events	PPGL	7	7
Total, other adverse events	Total	11	11
Total, serious adverse events	GEP-NET	1	4
Total, serious adverse events	PPGL	1	7
Total, serious adverse events	Total	2	11

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40198358	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
GEP-NET vs PPGL: Incidence of Adverse Events (AEs) and Lab Toxicities After 1st Lutathera Administration

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04711135

GET https://conductscience.org/api/trials/v1/NCT04711135/results?page=2

API reference For AI assistants