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New treatment option for Neuroendocrine Tumors
Official title Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial
ClinicalTrials.gov ID: NCT06855095
What this study is testing
What is Somatostatin analog?
Somatostatin analog is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for neuroendocrine tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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;
You likely can't join 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...
See the full eligibility 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.
- 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.).
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.