177Lu-PP-F11N in Combination With Sacubitril for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer

  • STATUS
    Recruiting
  • End date
    Feb 1, 2023
  • participants needed
    8
  • sponsor
    University Hospital, Basel, Switzerland
Updated on 10 October 2021
cancer
dotatate
targeted therapy
calcitonin
gastrin

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.

Description

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.

Details
Condition Medullary Thyroid Cancer, Medullary Thyroid Carcinoma, Thyroid Cancer, Medullary, Thyroid Cancer, Medullary, Thyroid Cancer, Medullary
Treatment 177Lu-PP-F11N, Sacuitril
Clinical Study IdentifierNCT03647657
SponsorUniversity Hospital, Basel, Switzerland
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Advanced MTC with elevated levels of calcitonin (> 100 pg/ml) and/or calcitonin-doubling time < 24 months before or after total thyroidectomy
Ga-DOTATOC PET/CT not older than 12 weeks
Age > 18 years
Informed consent

Exclusion Criteria

Medication with Vandetanib 3 weeks before the study and during the study
Renal failure (calculated glomerular filtration rate (GFR) < 60 ml/min per 1.73 m2 body surface)
Bone marrow failure (thrombocytes < 70 000/l, leucocytes < 2 500/l, hemoglobin < 8 g/dl)
Pregnancy and breast feeding
Known, serious side reaction in the case of a former application of pentagastrin
Active, second malignancy oder remission after second malignancy < 5 years
Age over 64 years
Systolic bood pressure < 112 mmHg at the time of screening
Simultaneous medication with angiotensin converting enzyme (ACE)-inhibitors, or withdrawal for less than 36 h prior to the medication with Entresto or simultaneous medication with AT-II-receptor blockers
Known intolerance to Sacubitril or Valsartan
Known angioedema in anamnesis in the context of a medication with an ACE-inhibitor or an AT-II-receptor blocker
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note