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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.
In the pilot (phase 0) study investigators will correlate the tumour detection rate with the surgery and histology (proof of concept study). Furthermore, kidney protection and dosimetry studies will be performed in order to determine the kidney protection protocol and starting activity for the dose escalation study in the following, dose escalation (phase I) study. In the phase I study investigators will determinate the maximum tolerated dose of 177Lu-PP-F11N in patients with MTC. Furthermore, correlation with tumour radiation dose and treatment response as well as organ radiation doses and maximal tolerated dose will be performed in order to allow prospective individual patient tailored therapy planning. In the phase I study, participation is additionally possible for patients with well differentiated GEP-NET (grade 1-3) with a Ki67 index of up to 55% or NET of the lung or thymus (grade 1 and 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 0: One arm; Phase I: One arm | Experimental | Phase 0: 6 patients, intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N with and without Physiogel (crossover) Phase I: expected 12 - 18 patients, intravenous application of max. 6 x 7-8 GBq 177Lu-PP-F11N (increasing number of applications by one in groups of three patients). All patients with or without Physiogel, depending on the results of the phase 0 study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 177Lu-PP-F11N | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 0: Scintigraphic visualisation rate | Phase 0 study: Evaluation of the scintigraphic visualisation of metastases after test injection, verification of 177Lu-PP-F11N uptake in metastases and correlation with surgery/histology if possible (poof of principle study). | up to 4 weeks |
| Phase I: Maximum tolerated dose | Phase I study: Determination of the maximum tolerated dose (MTD) | Up to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 0: Tumour-to-kidney radiation doses | Evaluation of the kidney radiation dose and the tumour-to-kidney radiation dose ratios with and without kidney protection (Physiogel). Composite measure. | 8 and 16 weeks |
| Phase 0: Radiation doses |
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Inclusion Criteria:
Phase 0 study
Phase I study
Exclusion Criteria:
Phase 0 study
Phase I study
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| Name | Affiliation | Role |
|---|---|---|
| Christof Rottenburger, Dr. med. | University Hospital, Basel, Switzerland | Principal Investigator |
| Damian Wild, Prof Dr Dr | University Hospital, Basel, Switzerland | 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 | Background | 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. | |
| 31519804 |
| Label | URL |
|---|---|
| Homepage University Hospital Basel | View source |
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| University Hospital Freiburg |
| OTHER |
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Calculation of tumour and organ radiation doses.
| 8 and 16 weeks |
| Phase 0: In vivo stability | Evaluation of in vivo stability of 177Lu-PP-F11N. | 8 and 16 weeks |
| Phase 0: Metabolites | Measurement of the metabolites of 177Lu-PP-F11N with and without Physiogel infusion. | 8 and 16 weeks |
| Phase I: Side reactions | Evaluation of side reactions of 177Lu-PP-F11N. | 8, 16 and 24 weeks |
| Phase 1: Biochemical response | Evaluation of biochemical response (decrease of calcitonin and calculation of calcitonin doubling time). | For the duration of 24 months. |
| Phase I: Morphological response | Evaluation of morphological therapy response (RECIST criteria). | 0, 3 and 12 months |
| Phase I: Tumour detection rate | Determination of the tumour detection rate and correlation with surgery/histology, if possible. | 8, 16 and 24 weeks |
| Phase I: Organ radiation doses | Calculation of organ radiation doses after therapy and correlation with the determined MTD (composite measure). | 8, 16 and 24 weeks |
| Phase 1: Overall survival | Determination of overall survival of patients after therapy. | Up to 5 years |
| Phase 1: In vivo stability | Evaluation of in vivo stability of 177Lu-PP-F11N. | 8, 16 und 24 weeks |
| Phase 1: Metabolites | Measurement of the metabolites of 177Lu-PP-F11N. | 8, 16 and 24 weeks |
| Background |
| Rottenburger C, Nicolas GP, McDougall L, Kaul F, Cachovan M, Vija AH, Schibli R, Geistlich S, Schumann A, Rau T, Glatz K, Behe M, Christ ER, Wild D. Cholecystokinin 2 Receptor Agonist 177Lu-PP-F11N for Radionuclide Therapy of Medullary Thyroid Carcinoma: Results of the Lumed Phase 0a Study. J Nucl Med. 2020 Apr;61(4):520-526. doi: 10.2967/jnumed.119.233031. Epub 2019 Sep 13. |
| ID | Term |
|---|---|
| C536914 | Thyroid cancer, medullary |
| D018276 | Carcinoma, Medullary |
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D018278 | Carcinoma, Neuroendocrine |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| 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 |
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