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| Name | Class |
|---|---|
| Krebsforschung Schweiz, Bern, Switzerland | OTHER |
| Center for Proton Therapy, Paul Scherrer Institute, Villigen,Switzerland | OTHER |
| University Hospital, Zürich | OTHER |
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The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of patients with advanced medullary thyroid carcinoma (MTC). 177Lu-PP-F11N is a gastrin analogon, binding to cholecystokinin-2 receptors. This receptors show an overexpression on more than 90 % of medullary thyroid carcinomas.
A phase 0 study (Lumed study part A) was already performed, showing low toxicity of 177Lu-PP-F11N and tumor uptake in all patients. Co-injection of Physiogel (Gelofusin) showed insignificant reduction of kidney uptake and can therefore be omitted for a radionuclide therapy with 177Lu-PP-F11N. In this study, the effect of the NEP-1 inhibitor Sacuitril on the in-vivo stability of 177Lu-PP-F11N and the uptake, respectively radiation doses in MTC metastases and organs will be evaluated, using a cross-over design already used for the Lumed part A study. Each patient will receive two injections of 177Lu-PP-F11N, with and without additional medication with Sacuitril Imaging findings, acquired by SPECT/CT, will be compared to imaging with 68Ga-DOTATOC positron emission tomography (PET)/CT. The inclusion of 8 patients is planned.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entresto second | Experimental | First intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N without and second injection with additional medication of Sacuitril (100 mg Entresto)(crossover) |
|
| Entresto first | Experimental | First intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N with and second injection without additional medication of Sacuitril (100 mg Entresto)(crossover) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 177Lu-PP-F11N | Drug | Intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N with and without co-medication with Sacuitril (100 mg Entresto) in each patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor radiation doses | Evaluation of the radiation doses in tumor tissue from MTC after injection of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto) | Measurement up to 72 hours after each injection of 177Lu-PP-F11N |
| Measure | Description | Time Frame |
|---|---|---|
| Kidney radiation doses | Evaluation of the radiation doses in the kidneys and the tumor-to-kidney dose ratios after injection of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto) | Measurement up to 72 hours after each injection of 177Lu-PP-F11N |
| Organ radiation doses |
| Measure | Description | Time Frame |
|---|---|---|
| Chromogranin A | Chromogranin A blood values will be compared to the radiation doses of the stomach. | Measurement up to 72 hours after the first injection of 177Lu-PP-F11N |
| 68Ga-DOTATOC PET/CT | Comparison of tumor imaging by 68Ga-DOTATOC PET/CT and 177Lu-PP-F11N SPECT/CT |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christof Rottenburger, Dr. med. | University Hospital Basel, Clinic for radiology and nuclear medicine | Principal Investigator |
| Damian Wild, PhD Dr | University Hospital Basel, Clinic for radiology and nuclear medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel, Clinic for radiology and nuclear medicine | Basel | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30002107 | Result | Sauter AW, Mansi R, Hassiepen U, Muller L, Panigada T, Wiehr S, Wild AM, Geistlich S, Behe M, Rottenburger C, Wild D, Fani M. Targeting of the Cholecystokinin-2 Receptor with the Minigastrin Analog 177Lu-DOTA-PP-F11N: Does the Use of Protease Inhibitors Further Improve In Vivo Distribution? J Nucl Med. 2019 Mar;60(3):393-399. doi: 10.2967/jnumed.118.207845. Epub 2018 Jul 12. | |
| 38581480 |
| Label | URL |
|---|---|
| University Hospital Basel Homepage | View source |
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| ID | Term |
|---|---|
| C536914 | Thyroid cancer, medullary |
| D018276 | Carcinoma, Medullary |
| ID | Term |
|---|---|
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
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| University Hospital Freiburg |
| OTHER |
Group 1 patients will receive first 177Lu-PP-F11N alone, second 177Lu-PP-F11N in combination with Sacuitril. Group 2 patients will first receive 177Lu-PP-F11N in combination with Sacuitril, second 177Lu-PP-F11N alone. Affiliation of patients to Groups 1 and 2 will be randomised.
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|
| Sacuitril | Drug | Medication with Sacuitril (100 mg Entresto) additional to the injection of 177Lu-PP-F11N |
|
|
Evaluation of the radiation doses in other organs and the appropriate organ-to-kidney dose ratios after injection of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto) |
| Measurement up to 72 hours after each injection of 177Lu-PP-F11N |
| In-vivo stability | Measurement (HPLC) of the in-vivo stability of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto). | Blood samples for measurement 5 and 30 minutes post injection of 177Lu-PP-F11N |
| Autoradiography | In case of surgery with available tumor tissue samples, imaging results will be compared with autoradiographic analysis of somatostatine- and CCK2-receptor expression in tumor tissue. | Through study completion, up to 18 months |
| Measurement up to 72 hours after each injection of 177Lu-PP-F11N |
| Derived |
| Rottenburger C, Hentschel M, Furstner M, McDougall L, Kottoros D, Kaul F, Mansi R, Fani M, Vija AH, Schibli R, Geistlich S, Behe M, Christ ER, Wild D. In-vivo inhibition of neutral endopeptidase 1 results in higher absorbed tumor doses of [177Lu]Lu-PP-F11N in humans: the lumed phase 0b study. EJNMMI Res. 2024 Apr 6;14(1):37. doi: 10.1186/s13550-024-01101-w. |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009380 | Neoplasms, Nerve Tissue |