Personalized therapy of metastatic thyroid cancer: biological characterization and optimization with 124I PET dosimetry

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fondazione IRCCS Istituto Nazionale Dei Tumori

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

Trial duration

12 May 2021 → ongoing

Decision date (initial)

2024-10-16

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-516273-80-00

EudraCT number

2020-002548-21

WHO UTN

U0000-0000-0000

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

-investigate if dosimetry-based 131I administration may increase efficacy as compared to that obtained with fixed activity, with an acceptable toxicity in DTC patients with soft tissue and skeletal metastasis:
-study if the mutational status, the gene expression and the variations of miRNA profiles before and after therapy of DTCs may be related to lesions’ refractoriness, even to personalized, 131I therapy

Secondary objectives 1

1. \

Conditions and MedDRA coding

Metastatic DTC

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Histo-pathological diagnosis of DTC
2. At least one documented non surgically-curable soft-tissue metastasis previously untreated
3. ECOG performance status = 0 - 1
4. Age ≥ 18 years old
5. Life expectancy > 6 months
6. 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
7. Preserved hematologic and renal function (hemoglobin > 10 g/dL; WBC > 3500/uL; neutrophilis > 50%; PLT > 100000/uL; albumin ≥ 2.5 g/dL; creatinine ≤ 2 mg/dL)
8. Signed informed consent

Exclusion criteria 14

1. All lesions surgically resectable
2. Minimal lymph neck nodal disease (diameter < 1 cm, up to 2 nodes)
3. Patient with skeletal metastases only
4. Only lung uniformly diffuse miliary micro-metastases without other measurable nodules criteria
5. Ongoing pregnancy (enrollment could be considered after delivery)
6. Breast-feeding (enrollment could be considered after suspension)
7. Refusal of male and female patients to use an effective contraception method during the study and for 6 months after completion of protocol therapy
8. Impossibility to undergo follow-up procedures
9. Presence of medical, psychiatric or surgical condition, not adequately controlled by treatment, which would likely affect subjects’ ability to complete the protocol
10. Assumption of any myelotoxic drugs
11. Previous or concomitant assumption of Amiodarone
12. Any other oncologic disease that required systemic treatment in the last 5 years. Cases who received previous loco-regional therapy on non-target lesions can be included (for example radiotherapy or surgery)
13. Participation in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives prior to the study drug.
14. Hypersensitivity: history of allergic reactions or hypersensitivity to the active substance, to any of the excipients, to any of the components of the radiolabelled radiopharmaceutical.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Evaluation of complete response (CR) rate on soft tissue metastases after a maximum of two radioiodine administrations optimized with personalized pre-treatment dosimetry based on 124I-PET/CT. The response will be considered 6 months [1] after the last optimized administration, as a combination of evaluations (RECIST, 124I-PET/CT, 18F-FDG, and thyroglobulin).

Secondary endpoints 3

1. Assessment of acute toxicity rate and severity
2. Assessment of the association among pre-treatment glucose metabolism, 124I uptake and therapy response
3. Assessment of the association among genetic mutations on cancer tissue, pre- and post-treatment miRNA expression, pre- and post-treatment glucose metabolism, iodine uptake, and 131I therapy response

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fondazione IRCCS Istituto Nazionale Dei Tumori

Sponsor organisation

Fondazione IRCCS Istituto Nazionale Dei Tumori

Address

Via Giacomo Venezian 1

City

Milan

Postcode

20133

Country

Italy

Scientific contact point

Organisation

Fondazione IRCCS Istituto Nazionale Dei Tumori

Contact name

S.C: Medicina Nucleare

Public contact point

Organisation

Fondazione IRCCS Istituto Nazionale Dei Tumori

Contact name

public relations office

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications