68Ga-GP-01 Injection in Solid Tumors Participants
ConditionSolid Tumor Malignancies
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGrandPharma (China) Co., Ltd.
About this trial
A company named Chengdu Shetai Medical Technology Co., Ltd. is conducting a research study to test a new type of scan for detecting solid tumors in patients who are scheduled for surgery.
During the scan, the investigators will use a special experimental drug called 68Ga-GP-01 Injection, which is given through a vein (IV). This drug isn't yet approved by the TGA for this use.
The scan works by targeting a protein called FAP that's often found in high amounts in tumor tissues. FAP is mainly present in cells surrounding tumors, but sometimes in cancer cells themselves too - especially in certain cancers like ovarian, breast, pancreatic, and some sarcomas. Researchers think this could be useful for both diagnosis and potential future treatments.
The GP-01 molecule is combined with a radioactive material (Gallium-68) that shows up on PET scans - a special imaging technique that can spot cancer cells in the body.
Currently, CT scans are the most common way to check for tumors before surgery. A PET/CT machine combines both technologies - it can show both the structure of participant's organs (CT) and detect cancer cells that have absorbed the radioactive tracer (PET).
In this study, the investigators want to see if 68Ga-GP-01 works better than standard PET/CT scans at finding tumors. After participant's surgery, the investigators will compare our scan results with participant's pathology report (the most accurate way to diagnose cancer) to check how accurate our method was.
Important: This is NOT a treatment for participant's cancer - it's just testing a new way to detect tumors.
About 20 patients at 4 Australian hospitals will participate. If participant is willing to join, participant's involvement will last about 2 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Agreed to participate by providing a signed informed consent form and can comply with study-related procedures.
Male or female aged ≥ 18 years old.
Patients with solid tumors planned to undergo surgical resection or laparoscopic exploration and histopathology confirmation.
Available CT/MRI images of suspected metastatic regions of cohort 1 patients; available CT/MRI images of both primary and metastatic regions of cohort 2 patients. .
Disqualifiers
Any PET scan done within 10 physical half-lives of the PET agent prior to planned administration of 68Ga-GP-01.
Exposure to any investigational agent within 4 weeks prior to the planned administration of 68Ga-GP-01.
Major surgery, any systemic anti-cancer therapy or radiotherapy within 4 weeks prior to planned administration of 68Ga-GP-01.
Past or current history of another malignancy, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least 3 years;
Trial design
Design model
Single group
Treatments tested in this trial
68Ga-GP-01 Injection
DrugA certain mass dose of 68Ga-GP-01 will be used in this study, and the radiation dose will be no more than, enabling all participants will receive a radiation dose of 5±2 mCi in the study.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Experimental GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the safety and tolerability of 68Ga-GP-01
Number of participants with treatment emergent adverse event, with abnormal laboratory tests results and abnormal 12-lead electrocardiograms (ECGs) readings.
Time frame
Within Day3 after doseLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: