Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial (ATSA)

February 26, 2025 updated by: The Netherlands Cancer Institute
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study population includes all patients aged over 18 with a neuroendocrine tumor grade I and II and a clinical indication for PRRT. Patients treated for at least three months with LA-SSA are randomized over two interventional arms: one arm where patients discontinue LA-SSA 4-6 weeks before the first PRRT treatment and one arm where patients continue LA-SSA treatment and receive the first PRRT administration within one week after the most recent LA-SSA injection. Patients in the control arm who have not been treated with LA-SSA in the last three months will start PRRT according to standard local protocol.

Study Type

Interventional

Enrollment (Estimated)

39

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
In this arm, patients without any LA-SSA treatment for at least 3 months prior to PRRT are included.
Active Comparator: 2A - LA-SSA injection 4-6 weeks before PRRT
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
Timing of LA-SSA injection prior to PRRT (either 4-6 weeks or 1-7 days).
Experimental: 2B - LA-SSA injection 1-7 days before PRRT
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
Timing of LA-SSA injection prior to PRRT (either 4-6 weeks or 1-7 days).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of continued LA-SSA use on the absorbed dose in tumor lesions during PRRT.
Time Frame: SPECT/CT after 4h, 24h, and 5-7 days post-injection
SPECT/CT after 4h, 24h, and 5-7 days post-injection

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of continued LA-SSA use on the absorbed dose in normal tissues during PRRT.
Time Frame: SPECT/CT after 4h, 24h, and 5-7 days post-injection and blood samples at 2h, 4h, 24h and 5-7 days post-injection
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.
Time Frame: SPECT/CT after 4h, 24h, and 5-7 days post-injection
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.
Time Frame: Blood samples at 2h, 4h, 24h and 5-7 days post-injection
Blood samples at 2h, 4h, 24h and 5-7 days post-injection

Other Outcome Measures

Outcome Measure
Time Frame
HRQoL assessments
Time Frame: At baseline, on the day of PRRT administration, 3 weeks after PRRT
At baseline, on the day of PRRT administration, 3 weeks after PRRT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Netherlands Cancer Institute

Collaborators

Neuroendocrine Tumor Research Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N23PRR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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