Protocol summary
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Study aim
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Initial evaluation of the therapeutic efficacy of 177Lu-FAPI in patients with various end-stage metastatic cancers resistant to standard therapies
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Design
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Clinical trial Phase I, One group of patients, with various end-stage metastatic cancers resistant to standard therapies
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Settings and conduct
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The study is on the palliative treatment of cancer in nuclear medicine using therapeutical radiopharmaceuticals.
The study will be performed in Hasheminejhad Hospital and Khatam hospital.
At first, PET/CT scan using the 68Ga-FAPI radiopharmaceutical or SPECT/CT scan using the 99mTc-FAPI will be performed.
The next step is treatment using 177Lu-FAPI (Beta emitter) intravenously injected. Then the SPECT imaging will show the accumulation sites of radiopharmaceutical.
The result of previous steps will determine the continuation of the therapy on individual patients.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: the patient should be able to understand and sign off the informed consent; the patient should be able to understand and follow the treatment protocol; patients should be older than 18; the patient's life expectancy should be over 6 months; patients should show no response to the standard treatment; the 68Ga-FAPI PET scan or 99mTc-FAPI SPECT scan should show 3 times more uptake of radiopharmaceutical in tumor to the liver of the patients; the patient with the progressive disease.
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Intervention groups
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Use of radiopharmaceutical 177Lu-FAPI-46 in the treatment of end-stage patients with metastatic cancer resistant to standard treatments of digestive system or breast
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Main outcome variables
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Pain feeling scale; patients’ ability to perform various ordinary tasks.
General information
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Reason for update
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"Considering the title change in the registered project in Researcher Page, I deemed it necessary to have the changes made on this website registered as well."
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20211206053304N1
Registration date:
2022-08-22, 1401/05/31
Registration timing:
prospective
Last update:
2023-07-26, 1402/05/04
Update count:
1
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Registration date
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2022-08-22, 1401/05/31
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-09-23, 1401/07/01
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Expected recruitment end date
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2023-03-19, 1401/12/28
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Initial evaluation of the therapeutic efficacy of 177Lu-FAPI in patients with various end-stage metastatic cancers resistant to standard therapies
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Public title
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177Lu-FAPI in cancer therapy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
the patient should be able to understand and sign off the informed consent.
The patient should be able to understand and follow the treatment protocol.
Patients should be older than 18.
The patients life expectancy should be over 6 months.
patients should show no response to the standard treatment.
The 68Ga-FAPI PET scan or 99mTc-FAPI SPECT scan should show 3 times more uptake of radiopharmaceutical in tumor to liver of the patients.
the patient with progressive disease should be included.
Exclusion criteria:
The patients who have received therapeutic radiopharmaceuticals like, 223Ra, 188Re, 186Re, 153Sm during last 6 months.
The patients are under systemic therapies like chemotherapy, immunotherapy, or biological treatment for cancer.
The patients who have been under any research treatment during 28 days before entrance in this study.
The patients who have shown any known allergy to the therapeutic radiopharmaceuticals.
The patients who have congestive heart failure.
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Age
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From 18 years old
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Gender
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Both
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Phase
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1
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Groups that have been masked
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No information
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Sample size
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Target sample size:
10
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-08-02, 1401/05/11
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Ethics committee reference number
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IR.IUMS.FMD.REC.1401.248
Health conditions studied
1
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Description of health condition studied
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end-stage metastatic gastrointestinal or breast cancer
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Amount of pain feeling on the bone
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Timepoint
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Just before treatment and every 4 weeks after treatment.
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Method of measurement
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Using Visual Analogue Scale questionnaire
2
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Description
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Performance Status (quality of life)
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Timepoint
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Before treatment and every 4 weeks after treatment.
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Method of measurement
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Eastern Cooperative Oncology Group (ECOG) Performance Status
Intervention groups
1
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Description
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Intervention group: the selected patients go through PET/CT (68Ga-FAPI radiopharmaceutical about 6 mCi dose) or SPECT/CT (99mTc-FAPI radiopharmaceutical about 20 mCi dose) scan at first. The therapeutical 177Lu-FAPI radiopharmaceutical ( about 86 mCi) will be injected. the manufacturare of the radiopharmaceuticals is Pars Isotope company. Then the scintigraphy will be done to show the radiopharmaceutical accumulation sits. based on the results of the study additional treatment will be evaluated and determined.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable