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Evaluating the theranostic application of Lu177-PSMA in management of refractory thyroid papillary cancer.

Protocol summary

Study aim
To evaluate the therapeutic effect of Lu177-PSMA in refractory but PSMA-avid papillary thyroid cancer
Design
This is a pilot single arm study with 10 patients that are eligible for this treatment based on the tumor board's opinion and their diagnostic evaluation.
Settings and conduct
Due to the low prevalence of eligible patients, there is only one case group. Patients in Isfahan Sayedshohada Cancer Center and Namazi Hospital in Shiraz, after being evaluatedthat by the tumor board, will undergo a diagnostic method with 68Ga-PSMA PET/CT or alternative imaging (Tc99m-PSMA) to determine their eligibility for the therapy with 177Lu-PSMA-617 will be planned for two to four cycles of 177Lu-PSMA therapy. The interval between each treatment cycle is 6 to 8 weeks based on the related guideline.
Participants/Inclusion and exclusion criteria
Patients with metastatic radio-iodine refractory papillary thyroid cancer with baseline, WBC>3000, Hb>9, platelete .cont>70000, AST and ALT<5*nl limit and Cr<2*nl are limited by a multidisciplinary tumor board. The data collected from these patients will be reviewed, and their eligibility for participating in the study will be evaluated. Patients who refused to participate in the study, life-expectancy of <1 month, a history of other concomittant cancers or other end-stage organ diseases, Patients with baseline, WBC<3000, Hb<9, platelete .cont<70000, AST and ALT>5*nl limit and Cr>2*nl limit, will be excluded from the study.
Intervention groups
All patients that have the criteria for the therapy will be planned for two to four cycles of 177Lu-PSMA therapy according to the level of response and the occurrence of the side effects after the first two cycles.
Main outcome variables
baseline serum thyroglobulin, post therapy thyroglobulin level, baseline PSMA avid lesions, post therapy PSMA- avid lesions

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230803059015N1
Registration date: 2023-08-14, 1402/05/23
Registration timing: prospective

Last update: 2023-08-14, 1402/05/23
Update count: 0
Registration date
2023-08-14, 1402/05/23
Registrant information
Name
Zeinab Amirkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 332 2578
Email address
znbamirkhaninew@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the theranostic application of Lu177-PSMA in management of refractory thyroid papillary cancer.
Public title
Effectiveness of Lu177-PSMA in treatment of refractory thyroid papillary cancer.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with metastatic radio-iodine refractory papillary thyroid cancer Patients with baseline, WBC>3000, Hb>9, platelete .cont>70000, AST and ALT<5*nl limit and Cr<2*nl limit
Exclusion criteria:
Patients who refused to participate in the study Life-expectancy of <1 month History of other concomittant cancer or other end-stage organ disease Patients with baseline, WBC<3000, Hb<9, platelete .cont<70000, AST and ALT>5*nl limit and Cr>2*nl limit
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
The multidisciplinary tumor board, consisting of a surgeon, an endocrinologist, a radio-oncologist, and a nuclear medicine specialist, will review the data of metastatic radioiodine refractory papillary thyroid cancer (RR-PTC) patients and evaluate their eligibility for participating in the study.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
5th floor, Shiraz University Central Building, Islamic Republic Boulevard
City
Shiraz
Province
Fars
Postal code
84471-71946.
Approval date
2023-02-28, 1401/12/09
Ethics committee reference number
IR.SUMS.REC.1402.077

Health conditions studied

1

Description of health condition studied
radio-iodine refractory papillary thyroid cancer
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
serum thyroglobulin level
Timepoint
Monthly
Method of measurement
Blood sampling

2

Description
PSMA avid lesions
Timepoint
Before and after completing the treatment
Method of measurement
Diagnostic method with ۶۸Ga-PSMA PET/CT or alternative imaging (Tc۹۹m-PSMA)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The multidisciplinary tumor board will decide whether patients were eligible for the treatment with 177Lu-PSMA-617. Patients will be considered eligible if one or more metastases were predominantly PSMA positive on 58Ga-PSMA PET/CT or Tc99m-PSMA SPECT/CT with no evidence of any non-PSMA/ non-iodine avid lesions. 10 Patients that have the criteria for the therapy, will be planned for two to four cycles of 177Lu-PSMA therapy according to rhe level of response and the occurrence of the side effects after the first two cycles. The administered activity will be between 150-200 GBq per cycle proportional to the number and avidity of PSMA-avid lesions. After the administration of ondansetron (8mg IV) and the application of icepack on salivary glands for 30 minutes, the therapeutic radiotracer will be administered by slow intravenous infusion in the inpatients setting with concomitant IV hydration with 1-2 L normal saline during 1-2 hours. In cases with cerebral or spinal metastasis and those with high metastatic volume, dexamethasone ۸mg will be administered daily from one day before the therapy to two days. The interval between each treatment cycle is 6 to 8 weeks based on the related guideline for use of Lu177-PSMA in the other metastatic cancers. During this period, CBc and renal function test will be evaluated every two weeks and will be recorded for the evaluation of any possible toxicity. The patients will be studied for at least 8 months after the therapy for the evaluation of their response to the therapy.
Category
Treatment - Drugs

2

Description
10 patients with radio-iodine refractory papillary thyroid cancer with other options of treatment like tyrosine kinase inhibitors and variables will compare in two groups
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Nuclear Medicine Department of Namazi Hospital in Shiraz
Full name of responsible person
Tahere Qaediyan
Street address
Nuclear Medicine Department, Namazi Hospital, Namazi Square, Zand Street
City
Shiraz
Province
Fars
Postal code
13311 – 71936
Phone
+98 71 3612 5315
Email
tghaedian@gmail.com

2

Recruitment center
Name of recruitment center
Nuclear Medicine Department of Sayedshohada Hospital in Isfahan
Full name of responsible person
Zeinab Amirkhani
Street address
Seyyed al-Shohada Hospital (AS), Nehar Farshadi Street, Khayam Street
City
Isfahan
Province
Isfehan
Postal code
8184917354
Phone
+98 913 332 2578
Email
Znbamirkhaninew@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Tahere Qaediyan
Street address
Nuclear Medicine Department, Namazi Hospital, Namazi Square, Zand Street
City
Shiraz
Province
Fars
Postal code
13311 – 71936
Phone
+98 71 3612 5315
Email
tghaedian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zeinab amirkhani
Position
Nuclear Medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
Seyyed al-Shohada Hospital (AS), Nehar Farshadi Street, Khayam Street
City
Isfahan
Province
Isfehan
Postal code
8184917354
Phone
+98 31 3236 6015
Email
Znbamirkhaninew@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Tahere Qaediyan
Position
Master of nuclear medicine
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
Zand Street, Namazi Square, Namazi Hospital, Nuclear Medicine Department
City
Shiraz
Province
Fars
Postal code
1331171936
Phone
+98 917 307 7729
Email
tghaedian@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zeinab amirkhani
Position
Nuclear Medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
Nuclear medicine department, Seyyed al-Shohada Hospital (AS), Nehar Farshadi Street, Khayam Street
City
Isfahan
Province
Isfehan
Postal code
8184917354
Phone
+98 31 3236 6015
Email
Znbamirkhaninew@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The results and the data related to the treatment method and how to perform the treatment will be provided to interested people.
When the data will become available and for how long
Access starts 6 months after publication of results
To whom data/document is available
All people interested in the subject of study
Under which criteria data/document could be used
It is accessible by maintaining the confidentiality of the data.
From where data/document is obtainable
Dr. Zainab Amirkhani, email znbamirkhaninew@gmail.Com
What processes are involved for a request to access data/document
The applicants should explain the reason for the request and the method of trust through email, and if the project managers agree, the results will be provided for them.
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