Clinical evaluation of 68Ga-SSSLTVSPWY peptide for evaluation of HER2 overexpression status in patients with breast cancer with PET/CT and compare to 18FDG
Diagnosis and determination of HER2 status in primary and metastatic lesions in breast cancer
Design
Ten non-randomized breast cancer patients confirmed by the inclusion criteria will be considered for a phase I clinical study by HER2 spot and whole-body imaging.
Settings and conduct
The SSSLTVSPWY peptide was labeled with gallium-68 to determine HER2 status for subsequent treatment plans in breast cancer patients. The study site is Khatam Hospital in Tehran, and PET imaging is performed after radiopeptide injection. The study is not blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female patients with HER2-overexpressed breast tumors (primary or metastatic mass) after screening with an IHC test (with 3+ result) or FISH test;
Exclusion criteria: Pregnancy, Breastfeeding, uncontrolled kidney, and liver disorders, and history of allergy to radiopharmaceuticals
Intervention groups
The intervention group includes patients with HER2-positive breast cancer. A peptidic kit (Schafer-N Company (Denmark)) would be labeled with gallium-68 (Parsisotope) in the nuclear medicine department of Khatam Al-Anbiya hospital, and a single dose of 20 μg would be injected intravenously into the patients. Imaging would be performed using positron emission tomography (PET) and the results would ultimately compare with standard radiopharmaceutical 18FDG.
Main outcome variables
Maximum standardized uptake value (SUVmax) by tumor; Ratio of tumor radioactivity to breast glandular tissue; Specificity; Sensitivity; Dosimetry; Positive and negative predictive value; Localization of tumor;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230312057691N1
Registration date:2023-04-10, 1402/01/21
Registration timing:registered_while_recruiting
Last update:2023-04-10, 1402/01/21
Update count:0
Registration date
2023-04-10, 1402/01/21
Registrant information
Name
Fatemeh Ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3368 5510
Email address
f.ebrahimi84@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of 68Ga-SSSLTVSPWY peptide for evaluation of HER2 overexpression status in patients with breast cancer with PET/CT and compare to 18FDG
Public title
Clinical evaluation of the SSSLTVSPWY peptide labeled with 68Ga
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with HER2-overexpressed breast tumors (primary or metastatic mass) after screening with IHC test (with 3+ result) or FISH test
Exclusion criteria:
Pregnancy
Breastfeeding
Uncontrolled kidney and liver disorders
A history of allergy to radiopharmaceuticals
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
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
The ethics committee of Mazandaran University of Medical Sciences
Street address
Beginning of Valiasr Highway, Three Way Jouybar,
City
Sari
Province
Mazandaran
Postal code
33971-48157
Approval date
2023-03-14, 1401/12/23
Ethics committee reference number
IR.MAZUMS.REC.1401.551
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50.91
ICD-10 code description
Malignant neoplasm of breast of unspecified site, female
Primary outcomes
1
Description
Maximum standardized uptake value (SUVmax) radioactivity by tumor
Timepoint
Imaging of the breast at 0.5,1,2 and 4 hours after the administration of the radiotracer
Method of measurement
PET/CT imaging
2
Description
Ratio of tumor radioactivity to breast glandular tissue
Timepoint
Imaging of the breast at 0.5,1,2 and 4 hours after the administration of the radiotracer
Method of measurement
PET/CT imaging
3
Description
Specificity
Timepoint
Imaging of the breast at 0.5,1,2 and 4 hours after the administration of the radiotracer
Method of measurement
PET/CT imaging
4
Description
Sensitivity
Timepoint
Imaging of the breast at 0.5,1,2 and 4 hours after the administration of the radiotracer
Method of measurement
PET/CT imaging
5
Description
Dosimetry
Timepoint
Imaging of the breast at 0.5,1,2 and 4 hours after the administration of the radiotracer
Method of measurement
PET/CT imaging
6
Description
Positive and negative predictive value
Timepoint
Imaging of the breast at 0.5,1,2 and 4 hours after the administration of the radiotracer
Method of measurement
PET/CT imaging
7
Description
Localization of tumor
Timepoint
Imaging of the breast at 0.5,1,2 and 4 hours after the administration of the radiotracer
Method of measurement
PET/CT imaging
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group includes patients with HER2-positive breast cancer. This evaluation is a diagnostic method using the positron emission tomography (PET) modality, in which the labeled peptide radiopharmaceutical with gallium-68 (Parsisotope) is prescribed to patients in a single dose of 20 μg. A Danish company (Schafer-N Company (Denmark)) would prepare the mentioned peptide and there is a chemical analysis that confirms its purity. The intended radiopharmaceutical is labeled and formulated in Khatam Al-Anbiya hospital, Tehran, and the radiochemical quality and purity would be checked and confirmed before administration to the patient. Radiolabelled medicine, would be injected in a single dose intravenously. The place of injection is in the nuclear medicine department of Khatam Al-Anbiya hospital, where there is necessary medical equipment and a doctor in case the patient suffers complications from the injection, for the prevention and treatment of the patients. The results would ultimately compare with standard radiopharmaceutical 18FDG.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Al-Anbiya Hospital
Full name of responsible person
Dr. Mahdi Akhlaghi
Street address
Rashid Yasemi Street، Upper than Mirdamad St.، Vali- Asr St.