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

Sponsor
The Netherlands Cancer Institute
Study ID
NCT06855095
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Mar 3, 2025
Start date
Jun 25, 2024
Status verified
Feb 2025
Primary completion
Jan 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
39 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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 ]

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