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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06855095
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2/Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The Netherlands Cancer Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Netherlands
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroendocrine Tumors, Neuroendocrine Tumor Grade 1, Neuroendocrine Tumor Grade 2, Neuroendocrine Neoplasm

Additional Details

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.

Arms & Interventions

Arms

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.

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.

Interventions

Drug: - Somatostatin analog

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Antoni van Leeuwenhoek, Amsterdam, Netherlands

Status

Recruiting

Address

Antoni van Leeuwenhoek

Amsterdam, ,

Site Contact

Stokkel

[email protected]

+31205129111

Clinical Trial Finder