177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer. (Lumed)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02088645|
Recruitment Status : Recruiting
First Posted : March 17, 2014
Last Update Posted : August 5, 2020
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).
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Cancer, Medullary Neuroendocrine Tumor of the Lung Grade 1 and 2 Neuroendocrine Tumor of the Thymus Grade 1 and 2 Neuroendocrine Tumor GEP Grade 1-3||Drug: 177Lu-PP-F11N||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||177Lu-PP-F11N for Receptor Targeted Therapy and Imaging (Theranostics) of Metastatic Medullary Thyroid Cancer - a Pilot and a Phase I Study.|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||March 2022|
Experimental: Phase 0: One arm; Phase I: One arm
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.
- Phase 0: Scintigraphic visualisation rate [ Time Frame: up to 4 weeks ]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).
- Phase I: Maximum tolerated dose [ Time Frame: Up to 9 months ]Phase I study: Determination of the maximum tolerated dose (MTD)
- Phase 0: Tumour-to-kidney radiation doses [ Time Frame: 8 and 16 weeks ]Evaluation of the kidney radiation dose and the tumour-to-kidney radiation dose ratios with and without kidney protection (Physiogel). Composite measure.
- Phase 0: Radiation doses [ Time Frame: 8 and 16 weeks ]Calculation of tumour and organ radiation doses.
- Phase 0: In vivo stability [ Time Frame: 8 and 16 weeks ]Evaluation of in vivo stability of 177Lu-PP-F11N.
- Phase 0: Metabolites [ Time Frame: 8 and 16 weeks ]Measurement of the metabolites of 177Lu-PP-F11N with and without Physiogel infusion.
- Phase I: Side reactions [ Time Frame: 8, 16 and 24 weeks ]Evaluation of side reactions of 177Lu-PP-F11N.
- Phase 1: Biochemical response [ Time Frame: For the duration of 24 months. ]Evaluation of biochemical response (decrease of calcitonin and calculation of calcitonin doubling time).
- Phase I: Morphological response [ Time Frame: 0, 3 and 12 months ]Evaluation of morphological therapy response (RECIST criteria).
- Phase I: Tumour detection rate [ Time Frame: 8, 16 and 24 weeks ]Determination of the tumour detection rate and correlation with surgery/histology, if possible.
- Phase I: Organ radiation doses [ Time Frame: 8, 16 and 24 weeks ]Calculation of organ radiation doses after therapy and correlation with the determined MTD (composite measure).
- Phase 1: Overall survival [ Time Frame: Up to 5 years ]Determination of overall survival of patients after therapy.
- Phase 1: In vivo stability [ Time Frame: 8, 16 und 24 weeks ]Evaluation of in vivo stability of 177Lu-PP-F11N.
- Phase 1: Metabolites [ Time Frame: 8, 16 and 24 weeks ]Measurement of the metabolites of 177Lu-PP-F11N.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088645
|Contact: Christof Rottenburger, Dr. med.||0041613286551||Christof.Rottenburger@usb.ch|
|Contact: Damian Wild, Prof Dr Dremail@example.com|
|University Hospital Basel, Clinic for radiology and nuclear medicine||Recruiting|
|Basel, Switzerland, 4031|
|Contact: Christof Rottenburger, Dr. med. 0041613286551 firstname.lastname@example.org|
|Principal Investigator:||Christof Rottenburger, Dr. med.||University Hospital, Basel, Switzerland|
|Study Director:||Damian Wild, Prof Dr Dr||University Hospital, Basel, Switzerland|