Metastatic Thyroid Cancer Therapy Optimization With 124I PET Dosimetry (131THEROPT124)

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    50
  • sponsor
    Carlo Chiesa
Updated on 25 April 2022

Summary

Failure of conventional radioiodine therapy of metastatic differentiated thyroid cancer could be explained by:

  • a suboptimal therapeutic approach, based on the administration of empirically fixed amount of radioactivity
  • the presence of lesions with impaired iodine uptake, due to the expression of specific mutations

The study aims to:

  • optimize therapy with pre-treatment 124-I blood and lesion dosimetry
  • collect genetic data to check if specific mutations and/or miRNA over-expression could be related to low iodine uptake or to radioresistance

Description

TRIAL DESIGN

This is a one-stage, phase II, single-arm, bi-centric study. Enrollment centres are the Istituto Nazionale Tumori in Milan, and the Sacro Cuore Don Calabria Hospital in Negrar, close to Verona. Both centres are located in North Italy. 124-I is produced by cyclotron in Negrar Radiopharmacy unit, while high-activity 131-I therapy will be delivered in Milan.

Patients with ascertained metastatic differentiated thyroid cancer are studied with FDG PET and CT. 124-I blood and lesion PET dosimetry is used to optimize the 131-I therapeutic activity. The same 124-I PET scans are repeated 6 months after therapy as response assessment. 124-I and 131-I administration are performed after hormon withdrawal.

Primary tumour tissue and circulating miRNA will be analyzed to check the genetical features.

According to 124-I dosimetric PET data published by Jentzen et al, good efficacy (Tumour Control Probability > 80%) is obtained with absorbed dose > 80 Gy to soft tissue metastases, and > 650 Gy to bone metastases. Seen this difference, only soft tissue lesions are considered as target for the calculation of the complete response rate.

However, for ethical reasons, therapeutic activity will be chosen in order to be effective both on soft tissue and bone lesions. Patients with too low predicted lesion absorbed dose even administering the Maximum Tolerable Activity (2 Gy to blood) will exit the protocol to receive the standard of care.

PRIMARY END-POINT

Evaluation of complete response (CR) rate on soft tissue metastases 6 months after treatment, or later. The best response will be considered.

SECONDARY END-POINTS

Assessment of:

  • acute toxicity rate and severity
  • the association among pre-treatment glucose metabolism, 124-I uptake and therapy response
  • the association among genetic mutations (BRAF V600E, TERT promoter, others) on thyroid cancer tissue, pre- and post-treatment miRNA expression, pre- and post-treatment glucose metabolism, iodine uptake, and 131-I therapy response

SAMPLE SIZE AND POPULATION

By considering a complete response (CR) rate in patients of soft tissue metastases after fixed activity approach as published by Klubo-Gwiezdzinska et al and by assuming an increment of 15% in CR rate after dosimetry-based administration, 46 evaluable patients will be required to test the above hypotheses.

Details
Condition Metastatic Differentiated Thyroid Cancer
Treatment Radioiodine optimized therapy
Clinical Study IdentifierNCT05299437
SponsorCarlo Chiesa
Last Modified on25 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histo-pathological diagnosis of DTC
At least one documented non surgically-curable soft-tissue metastasis previously untreated
ECOG performance status = 0 - 1
Life expectancy > 6 months
Females of childbearing age must have negative serum pregnancy test prior to registration and agree to use birth control throughout the study and for 6 months after completion of therapy
Preserved hematologic and renal function (hemoglobin > 10 g/dL; WBC > 3500/uL; neutrophils > 50%; PLT > 100000/uL; albumin ≥ 2.5 g/dL; creatinine ≤ 2 mg/dL)
Signed informed consent

Exclusion Criteria

All lesions surgically resectable
Minimal lymph nodal disease (diameter < 1 cm, up to 2 nodes)
Patient with skeletal metastases only
Lung diffuse miliary micro-metastases
Ongoing pregnancy
Breast-feeding (enrollment could be considered after suspension)
Refusal of male and female patients to use an effective contraception method during the study and for 6 months after completion of protocol therapy
Impossibility to undergo follow-up procedures
Presence of medical, psychiatric or surgical condition, not adequately controlled by treatment, which would likely affect subjects' ability to complete the protocol
Assumption of any anti-tumor therapy including chemotherapy, biological or investigational drug treatments
Assumption of any myelotoxic drugs
Previous or concomitant assumption of Amiodarone
Any other oncologic disease that required treatment in the last 5 years
Participation in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives prior to the study drug
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...

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