A Study of Peptide Receptor Radionuclide Therapy (PRRT) U... | NCT07653126

Studies
A Study of Peptide Receptor Radionuclide Therapy (PRRT) Use in Neuroendocrine Tumor (NET) Patients in Germany

NCT07653126

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Jun 17, 2026Actual

Enrollment

117Actual

Phase

Not provided

Conditions

Gastro-enteropancreatic Neuroendocrine Tumor

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 3, 2023Actual

Primary Completion Date

Sep 29, 2023Actual

Completion Date

Sep 29, 2023Actual

First Submitted Date

Jun 12, 2026

First Submission Date that Met QC Criteria

Jun 12, 2026

First Posted Date

Jun 17, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2026

Last Update Posted Date

Jun 17, 2026Actual

Description Module

Brief Summary

The aim of this study was to assess patient characteristics and treatment patterns of gastro-enteropancreatic neuroendocrine tumor (GEP-NET) patients who received PRRT in German routine care.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

117Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PRRT Cohort		Adult GEP-NET patients who received PRRT in German routine care.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Baseline Demographics		Baseline
Number of Patients by Tumor Status		Baseline
Duration Between Initial Diagnosis and Initiation of Primary PRRT		Baseline
Number of Patients by PRRT Line of Therapy		Approximately 1 year
Number of Patients by Type of PRRT Received		Approximately 1 year
PRRT Dosage		Approximately 1 year
Number of Patients by Treatment Interval		Approximately 1 year
Number of Patients by Co-medication		Approximately 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Patients with a confirmed diagnosis of GEP-NET (any localization of the primary tumor including cancer of unknown primary origin [CUP], any Grade).
Patients with a first cycle of primary PRRT of home-brew 177Lu-DOTATATE/DOTATOC or Lutathera® between 01 July 2020 and 30 June 2021.

Exclusion criteria:

Received a combination of PRRT with chemotherapy.
Received a combination of PRRT with a radionuclide other than lutetium-177 (e.g., yttrium-90).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult GEP-NET patients in Germany who received their first cycle of primary PRRT between 01 July 2020 and 30 June 2021.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Essen			Germany
Novartis Investigative Site

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
C535650	Gastro-enteropancreatic neuroendocrine tumor
D018358	Neuroendocrine Tumors

Ancestor Terms

ID	Term
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided