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New treatment option for Colorectal Cancer
Official title Study to Evaluate the Diagnostic Performance of GEH300079 (68Ga) Injection PET/CT for Detection of PC in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)
ClinicalTrials.gov ID: NCT07219238
What this study is testing
What is GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT)?
GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a Phase 2/3, prospective, multicenter, open-label, non-randomized clinical trial, in which GEH300079 (68Ga) PET/CT images will be acquired in patients with primary colorectal, gastric, ovarian, or Pancreatic Ductal Adenocarcinoma (PDAC) cancers and known or suspected Peritoneal Carcinomatosis (PC) before or after institutional Standard of Care (SoC) imaging. The primary objective is to evaluate the diagnostic performance of GEH300079 (68Ga) PET/CT for the detection of PC in patients with colorectal, gastric, or ovarian primary cancers, using a composite standard of truth (SoT), in a region-based analysis.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant is ≥18 years of age
- Participant has provided signed informed consent before any study-specific screening procedures
- Participant has histopathologically confirmed primary colorectal, gastric or ovarian cancer or PDAC
- Participant has known or suspected PC from the tumor of origin. Suspicion may be based on imaging or clinical findings.
- Participant is scheduled for peritoneal surgery with curative intent, surgical exploration, or laparoscopy, with either: a. No neoadjuvant treatment...
You likely can't join if
- Participant is pregnant or breast-feeding, or sexually active and not using or not willing to use an acceptable form of birth control from screening...
- Participant has a known disorder that, in the opinion of the investigator, will impact the study procedures
- Participant needs any intervention that would delay study participation
- Participant has non-resectable extra-abdominal metastasis and/or \>3 hepatic metastases on standard work up
- Participant will not be able to complete the study, based on their anticipated life expectancy
- Participant has active bacterial, viral, or fungal infection requiring systemic antibacterial, anti-viral or antifungal therapy (topical medications...
See the full eligibility criteria
- Participant is ≥18 years of age
- Participant has provided signed informed consent before any study-specific screening procedures
- Participant has histopathologically confirmed primary colorectal, gastric or ovarian cancer or PDAC
- Participant has known or suspected PC from the tumor of origin. Suspicion may be based on imaging or clinical findings.
- Participant is scheduled for peritoneal surgery with curative intent, surgical exploration, or laparoscopy, with either: a. No neoadjuvant treatment received, treatment-naïve (i.e., undergoing upfront surgery or...
- Participant has Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Participant is able and willing to comply with all study procedures as described in the protocol
- Participant is pregnant or breast-feeding, or sexually active and not using or not willing to use an acceptable form of birth control from screening up to 30 days after receiving the investigational medicinal product...
- Participant has a known disorder that, in the opinion of the investigator, will impact the study procedures
- Participant needs any intervention that would delay study participation
- Participant has non-resectable extra-abdominal metastasis and/or \>3 hepatic metastases on standard work up
- Participant will not be able to complete the study, based on their anticipated life expectancy
- Participant has active bacterial, viral, or fungal infection requiring systemic antibacterial, anti-viral or antifungal therapy (topical medications are permitted)
- Participant has renal function impairment as defined by:
- For Phase 2: estimated glomerular filtration rate less than 60 mL/min
- For Phase 3: estimated glomerular filtration rate less than 30 mL/min
- Participant has severe hepatic function impairment as defined by:
- Aspartate aminotransferase (serum glutamic-oxaloacetic transaminase) and alanine aminotransferase (serum glutamic-pyruvic transaminase): ≤2.5 × upper limit of normal (ULN; ≤5 × ULN for participants with liver metastases)
- Bilirubin: ≤1.5 × ULN or direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN
- Participant has autoimmune disease that required systemic treatment in the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed
- Participant has serious co-morbidities or serious non-malignant disease that in the opinion of the investigator, could compromise participant safety and/or protocol objectives
- Participant either received or is planning to receive any other investigational agent within the 28 days prior to the first imaging visit or during study participation (with the exception of the 3-month follow-up period)
- Participant has known or suspected hypersensitivity to any excipients used in GEH300079 (68Ga)
- Participant has severe claustrophobia, is unable to lie flat or fit into the scanner, or is unable to tolerate the PET/CT scan for any reason
- (Phase 3 only) Participant was previously included in Phase 2 of this study
The study team makes the final eligibility decision.
Where it's taking place
- Grand Rapids, Michigan, United States
- Stockholm, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grand Rapids, Michigan, United States; Stockholm, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.