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NCT06855095RecruitingPhase 2/3

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

Source: ClinicalTrials.gov · Last updated 3 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
39 (estimated)
First submitted
25 Oct 2023
Start date
25 Jun 2024
Primary completion date
1 Jan 2027
Lead sponsor
The Netherlands Cancer Institute
NCT number
NCT06855095

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 39
  • From 25 Jun 2024 to the primary completion date, 1 Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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.).

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Antoni van Leeuwenhoek
Coordinator of this site? Confirm its status
AmsterdamNetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.