Trials / Active Not Recruiting
Active Not RecruitingNCT02088645
177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer.
177Lu-PP-F11N for Receptor Targeted Therapy and Imaging (Theranostics) of Metastatic Medullary Thyroid Cancer - a Pilot and a Phase I Study.
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- University Hospital, Basel, Switzerland · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 177Lu-PP-F11N |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2026-06-01
- Completion
- 2027-06-01
- First posted
- 2014-03-17
- Last updated
- 2025-02-24
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT02088645. Inclusion in this directory is not an endorsement.