To evaluate the efficacy of the 177Lu-DOTA-FAPI therapy in patients with various types of cancers
Design
This is an interventional, phase 2 clinical trial with 30 patients,
enrolled between September 2021 to September 2023, which will be followed between treatment sessions
Settings and conduct
Patients are selected and justified in the nuclear medicine center at the Bushehr Nuclear Medicine department. The consent form is obtained and finally, the treatment will be performed with intravenous injection of 7.4 GBq (200mCi) of 177Lu-DOTA-FAPI. 24 and 48 hours after injection, patients will be undergone whole-body scan for the assessment of radiotracer distribution. Six to eight weeks after the 177Lu-DOTA-FAPI therapy, the patients will be visited by oncologists and nuclear medicine physicians and if there was not any toxicity, the next treatment session will be performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with confirmed FAP receptors detected by 68Ga-DOTA-FAPI PET/CT or 99mTc-DOTA-FAPI SPECT, having suitable hematologic parameters and ECOGP Status ≤ 2 who are able to provide informed consent. Exclusion criteria: Pregnant or lactating women; significant bleeding within two weeks prior to trial entry; heart disorders; uncontrolled bacterial, viral, or fungal infection; having psychiatric illness/social situations that would interfere with compliance with study requirements.
Intervention groups
We are going to use a single group of patients to evaluate the efficiency of 177Lu-DOTA-FAPI in treatment of different cancers expressing FAP receptors.
Main outcome variables
Objective Tumour Response Rate - defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) divided by the total number of participants.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210612051548N2
Registration date:2021-09-28, 1400/07/06
Registration timing:registered_while_recruiting
Last update:2021-09-28, 1400/07/06
Update count:0
Registration date
2021-09-28, 1400/07/06
Registrant information
Name
Majid Assadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3332 0361
Email address
assadipoya@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficiency of 177Lu-DOTA-FAPI Therapy in Treatment of Patients With Various Types of Cancer (Primary Locally Advanced or Metastatic Cancers)
Public title
177Lu-DOTA-FAPI Therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of at least one tumoral lesion detected by 68Ga-DOTA-FAPI PET/CT or 99mTc-DOTA-FAPI SPECT
Having hematologic parameters as: (i) Absolute neutrophil count ≥ 1000 cells/mm3; (ii) Platelet count ≥ 100,000/mm3; (iii) Hemoglobin ≥ 8 g/dL
Participants who sign the informed consent form which was assented according to the guidelines of the Clinical Research Ethics Committee (signed by participant, parent, or legal representative).
Eastern Cooperative Oncology Group Performance Status (ECOG) ≤ 2
Exclusion criteria:
Patient had history of class 3 or 4 congestive heart failure (CHF)
Patient had clinically significant bleeding within two weeks prior to trial entry (e.g. gastrointestinal bleeding, intracranial bleeding)
Pregnant or lactating women
Patient have psychiatric illness/social situations that would interfere with compliance with study requirements
Patient cannot undergo PET/CT or SPECT scanning because of weight limits
Patient had an active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
Age
From 18 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Bushehr province university of medical sciences
Street address
Bushehr University of Medical Science, Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Approval date
2021-06-27, 1400/04/06
Ethics committee reference number
IR.BPUMS.REC.1400.045
2
Ethics committee
Name of ethics committee
Research Ethics Committees of Bushehr province university of medical sciences
Street address
Bushehr University of Medical Science, Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Approval date
2021-06-27, 1400/04/06
Ethics committee reference number
IR.BPUMS.REC.1400.047
3
Ethics committee
Name of ethics committee
Research Ethics Committees of Bushehr province university of medical sciences
Street address
Bushehr University of Medical Science, Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Approval date
2021-06-27, 1400/04/06
Ethics committee reference number
IR.BPUMS.REC.1400.048
4
Ethics committee
Name of ethics committee
Research Ethics Committees of Bushehr province university of medical sciences
Street address
Bushehr University of Medical Science, Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Approval date
2021-06-27, 1400/04/06
Ethics committee reference number
IR.BPUMS.REC.1400.043
5
Ethics committee
Name of ethics committee
Research Ethics Committees of Bushehr province university of medical sciences
Street address
Bushehr University of Medical Science, Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Approval date
2021-06-27, 1400/04/06
Ethics committee reference number
IR.BPUMS.REC.1400.046
6
Ethics committee
Name of ethics committee
Research Ethics Committees of Bushehr province university of medical sciences
Street address
Bushehr University of Medical Science, Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Approval date
2021-06-27, 1400/04/06
Ethics committee reference number
IR.BPUMS.REC.1400.049
7
Ethics committee
Name of ethics committee
Research Ethics Committees of Bushehr province university of medical sciences
Street address
Bushehr University of Medical Science, Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Approval date
2021-06-27, 1400/04/06
Ethics committee reference number
IR.BPUMS.REC.1400.044
8
Ethics committee
Name of ethics committee
Research Ethics Committees of Bushehr province university of medical sciences
Street address
Bushehr University of Medical Science, Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Approval date
2021-06-27, 1400/04/06
Ethics committee reference number
IR.BPUMS.REC.1400.042
Health conditions studied
1
Description of health condition studied
Brain tumors
ICD-10 code
C71
ICD-10 code description
Malignant neoplasm of brain
2
Description of health condition studied
Thyroid cancer resistant to radioactive iodine therapy
ICD-10 code
C73
ICD-10 code description
Malignant neoplasm of thyroid gland
3
Description of health condition studied
Gastrointestinal tumor
ICD-10 code
C15-C26
ICD-10 code description
Malignant neoplasms of digestive organs
4
Description of health condition studied
Lung cancer
ICD-10 code
C34
ICD-10 code description
Malignant neoplasm of bronchus and lung
5
Description of health condition studied
Prostate cancer
ICD-10 code
C61
ICD-10 code description
Malignant neoplasm of prostate
6
Description of health condition studied
Malignant female genital organs
ICD-10 code
C57.8
ICD-10 code description
Malignant neoplasm of overlapping sites of female genital organs
7
Description of health condition studied
Urinary tract cancer
ICD-10 code
C68.9
ICD-10 code description
Malignant neoplasm of urinary organ, unspecified
8
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
9
Description of health condition studied
Malignant neoplasm of head, face and neck
ICD-10 code
C49.0
ICD-10 code description
Malignant neoplasm of connective and soft tissue of head, face and neck
Primary outcomes
1
Description
Objective Tumour Response Rate - defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) divided by the total number of participants.
Timepoint
6-8 week after last session of treatment
Method of measurement
Observation and semi-quantification analysis via PET/CT imaging
Secondary outcomes
1
Description
Progression free survival (PSF)
Timepoint
Average 2 years
Method of measurement
Medical imaging
Intervention groups
1
Description
Intervention group: In this study, 7.4 GBq (200 mCi) of 177Lu-DOTA-FAPI is injected intravenously into 30 patients with various types of cancers that demonstrated high FAP expression according to the 68Ga-DOTA-FAPI PET/CT or 99mTc-DOTA-FAPI SPECT. Then whole-body scan is performed at 24 hours, and 48 hours after injection to assess radiotracer distribution. Six to eight weeks after the 177Lu-DOTA-FAPI therapy, the patients will be visited by oncologists and nuclear medicine physicians and if there was not any toxicity, the next treatment session will be performed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Persian Gulf Hospital
Full name of responsible person
Majid Assadi
Street address
The nuclear medicine center, Persian Gulf hospital, Taleghani street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3345 5375
Fax
Email
assadipoya@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Gholamreza Khamisipour
Street address
Vice-Chancellor for Research and Technology of Bushehr University of Medical Sciences, Salman-e-Farsi Blvd,Bushehr,Iran.
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3345 0178
Fax
Email
khamisipourgholamreza@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Majid Assadi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
The Persian Gulf Nuclear Medicine Research Center, Bushehr University of Medical Sciences,Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3332 0361
Fax
+98 77 3332 0361
Email
assadipoya@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Majid Assadi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
The Persian Gulf Nuclear Medicine Research Center, Bushehr University of Medical Sciences,Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3332 0361
Fax
+98 77 3332 0361
Email
assadipoya@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Narges Jokar
Position
Research Instructor
Latest degree
Master
Other areas of specialty/work
Medical Physics
Street address
The Persian Gulf Nuclear Medicine Research Center, Bushehr University of Medical Sciences,Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3332 0361
Fax
+98 77 3332 0361
Email
narges.jokar69@gmail.com
Web page address
https://pgnmrc.bpums.ac.ir/fa/index.aspx
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
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When the data will become available and for how long
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To whom data/document is available
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Under which criteria data/document could be used
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From where data/document is obtainable
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What processes are involved for a request to access data/document