Clinical evaluation of the SSSLTVSPWY peptide labeled with 68Ga

Clinical evaluation of 68Ga-SSSLTVSPWY peptide for evaluation of HER2 overexpression status in patients with breast cancer with PET/CT and compare to 18FDG

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230312057691N1

Enrollment

Registered

2023-04-10

Start date

2023-04-04

Completion date

Unknown

Last updated

2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer. Malignant neoplasm of breast of unspecified site, female

Interventions

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 ra

Eligibility

Sex/Gender

Female

Inclusion 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

Exclusion criteria: Pregnancy Breastfeeding Uncontrolled kidney and liver disorders A history of allergy to radiopharmaceuticals

Design outcomes

Primary

Measure	Time frame
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.;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.;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.;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.;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.;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.;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.	—

Measure

Time frame

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.;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.;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.;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.;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.;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.;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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mahdi Akhlaghi

Tehran University of Medical Sciences

m-akhlaghi@sina.tums.ac.ir+98 21 8888 4040

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026