NCT06855095

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
10mo left

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jun 2024Mar 2027

First Submitted

Initial submission to the registry

October 25, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

June 25, 2024

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 3, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

2.5 years

First QC Date

October 25, 2023

Last Update Submit

February 26, 2025

Conditions

Neuroendocrine TumorsNeuroendocrine Tumor Grade 1Neuroendocrine Tumor Grade 2Neuroendocrine Neoplasm

Keywords

Peptide Receptor Radionuclide TherapyPRRTLutetiumDOTATATE

Outcome Measures

Primary Outcomes (1)

  • Effect of continued LA-SSA use on the absorbed dose in tumor lesions during PRRT.

    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.

    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.

    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.

    Blood samples at 2h, 4h, 24h and 5-7 days post-injection

Other Outcomes (1)

  • HRQoL assessments

    At baseline, on the day of PRRT administration, 3 weeks after PRRT

Study Arms (3)

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.

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.

Drug: Somatostatin analog

Interventions

Somatostatin analogDRUG

Timing of LA-SSA injection prior to PRRT (either 4-6 weeks or 1-7 days).

2A - LA-SSA injection 4-6 weeks before PRRT2B - LA-SSA injection 1-7 days before PRRT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antoni van Leeuwenhoek

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Somatostatin

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPancreatic HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2023

First Posted

March 3, 2025

Study Start

June 25, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 3, 2025

Record last verified: 2025-02

Locations

NL(1)