Metastatic Thyroid Cancer Therapy Optimization With 124I PET Dosimetry
NCT ID: NCT05299437
Last Updated: 2022-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2021-05-12
2024-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Use of 124-I-PET/CT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer
NCT03841617
Effect of Thyrotropin Level on Iodine Uptake in Metastatic Differentiated Thyroid Cancer
NCT04880798
Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma
NCT03647358
Radioiodine Dosimetry Protocol for Thyroid Cancer Metastases
NCT00749697
PET-TC in Thyroid Evaluation
NCT06852144
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Optimized therapy
Patients with ascertained metastatic differentiated thyroid cancer will be studied with FDG PET, CT, and for genetic characterization. 100 MBq of 124-I are administered for blood and PET lesion dosimetry.
According Jentzen et al, good efficacy (Tumour Control Probability \> 80%) is obtained with absorbed dose higher than 80 Gy to soft tissue metastases, and \> 650 Gy to bone metastases. These values ae pursued with the limit of 2 Gy to blood.
Only soft tissue lesions will be 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.
Radioiodine optimized therapy
124-I blood and lesion dosimetry will be used to optimize the 131-I therapeutic activity. Both 124-I and 131-I administration will be performed after hormon withdrawal.
Primary tumour tissue and circulating miRNA will be analyzed to check the genetic status.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Radioiodine optimized therapy
124-I blood and lesion dosimetry will be used to optimize the 131-I therapeutic activity. Both 124-I and 131-I administration will be performed after hormon withdrawal.
Primary tumour tissue and circulating miRNA will be analyzed to check the genetic status.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Associazione Italiana per la Ricerca sul Cancro
OTHER
Carlo Chiesa
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Carlo Chiesa
Medical Physics Expert
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carlo Chiesa, PhD
Role: PRINCIPAL_INVESTIGATOR
Nuclear Medicine, Fondazione IRCCS Istituto Nazionale Tumori
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nuclear Medicine, Ospedale Sacro Cuore - Don Calabria
Negrar, Verona, Italy
Nuclear Medicine, Fondazione IRCCS Istituto Nazionale Tumori
Milan, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Klubo-Gwiezdzinska J, Van Nostrand D, Atkins F, Burman K, Jonklaas J, Mete M, Wartofsky L. Efficacy of dosimetric versus empiric prescribed activity of 131I for therapy of differentiated thyroid cancer. J Clin Endocrinol Metab. 2011 Oct;96(10):3217-25. doi: 10.1210/jc.2011-0494. Epub 2011 Aug 17.
Nagarajah J, Janssen M, Hetkamp P, Jentzen W. Iodine Symporter Targeting with 124I/131I Theranostics. J Nucl Med. 2017 Sep;58(Suppl 2):34S-38S. doi: 10.2967/jnumed.116.186866.
Jentzen W, Verschure F, van Zon A, van de Kolk R, Wierts R, Schmitz J, Bockisch A, Binse I. 124I PET Assessment of Response of Bone Metastases to Initial Radioiodine Treatment of Differentiated Thyroid Cancer. J Nucl Med. 2016 Oct;57(10):1499-1504. doi: 10.2967/jnumed.115.170571. Epub 2016 May 19.
Jentzen W, Hoppenbrouwers J, van Leeuwen P, van der Velden D, van de Kolk R, Poeppel TD, Nagarajah J, Brandau W, Bockisch A, Rosenbaum-Krumme S. Assessment of lesion response in the initial radioiodine treatment of differentiated thyroid cancer using 124I PET imaging. J Nucl Med. 2014 Nov;55(11):1759-65. doi: 10.2967/jnumed.114.144089. Epub 2014 Oct 20.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AIRC 21939
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.