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| Name | Class |
|---|---|
| Neuroendocrine Tumor Research Foundation | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | In this arm, patients without any LA-SSA treatment for at least 3 months prior to PRRT are included. | |
| 2A - LA-SSA injection 4-6 weeks before PRRT | Active Comparator | 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. |
|
| 2B - LA-SSA injection 1-7 days before PRRT | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatostatin analog | Drug | Timing of LA-SSA injection prior to PRRT (either 4-6 weeks or 1-7 days). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of continued LA-SSA use on the absorbed dose in tumor lesions during PRRT. | SPECT/CT after 4h, 24h, and 5-7 days post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of continued LA-SSA use on the absorbed dose in normal tissues during PRRT. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HRQoL assessments | At baseline, on the day of PRRT administration, 3 weeks after PRRT |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antoni van Leeuwenhoek | Recruiting | Amsterdam | Netherlands |
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| 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. | Blood samples at 2h, 4h, 24h and 5-7 days post-injection |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D013004 | Somatostatin |
| ID | Term |
|---|---|
| D010905 | Pituitary Hormone Release Inhibiting Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010187 | Pancreatic Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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