GEH300079 PET/CT for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new imaging method, GEH300079 (68Ga) Injection PET/CT, to evaluate its effectiveness in detecting peritoneal carcinomatosis (PC), a cancer complication, in patients with primary cancers such as colorectal, gastric, ovarian, and pancreatic. The goal is to determine if this imaging technique surpasses standard methods in identifying PC. The trial consists of two phases: Phase 2 will determine the optimal dose and timing for the imaging, while Phase 3 will assess its safety and effectiveness in detecting PC in specific cancers. The trial seeks participants diagnosed with colorectal, gastric, ovarian, or pancreatic cancer who may have PC based on previous tests or symptoms. Participants should have surgery planned for their condition. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you have an active infection requiring systemic treatment, you may not be eligible to participate.
What prior data suggests that this PET/CT technique is safe for detecting peritoneal carcinomatosis?
Research has shown that GEH300079 (68Ga) PET/CT is generally safe for people. In earlier studies with similar agents like 68Ga-DOTATATE PET/CT, no serious side effects requiring treatment were reported, indicating it is well-tolerated.
Another study on a similar agent, 68Ga-FAPI, confirmed its safety for detecting cancer. This treatment is in an advanced testing stage, which usually means its safety is well understood. Overall, existing evidence supports the safety of GEH300079 (68Ga) PET/CT for cancer imaging.12345Why are researchers excited about this trial?
Researchers are excited about the GEH300079 (68Ga) PET/CT treatment for colorectal cancer because it offers a novel imaging approach that could enhance cancer detection and monitoring. Unlike traditional imaging methods, this treatment utilizes a radioactive tracer, GEH300079 (68Ga), which targets specific cancer cells, potentially allowing for more precise visualization of tumors. This method could lead to more accurate assessments of tumor spread and response to treatment, improving patient management and outcomes. Additionally, the ability to conduct multiple scans over a short period provides dynamic insights into tumor behavior, which is not typically possible with standard imaging techniques.
What evidence suggests that GEH300079 (68Ga) PET/CT is effective for detecting peritoneal carcinomatosis in colorectal cancer?
Research has shown that GEH300079 (68Ga) PET/CT scans effectively detect certain cancers. Studies have demonstrated that this imaging technique can identify recurrent colorectal cancer even when other scans fail. One study found the GEH300079 (68Ga) PET/CT scan to be 100% accurate in identifying cancer that had spread to the abdominal lining in patients with colorectal cancer, correctly detecting all such cases. In this trial, participants will receive a single IV bolus of GEH300079 (68Ga) to explore its potential to detect cancers more effectively than traditional methods.678910
Are You a Good Fit for This Trial?
This trial is for patients with primary colorectal, gastric, ovarian, or pancreatic cancers who are known or suspected to have Peritoneal Carcinomatosis (PC). They should be scheduled for Standard of Care imaging. Details on specific inclusion and exclusion criteria are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 2
Phase 2 aims to confirm the statistical and scientific assumptions for the Phase 3 part, and to confirm the optimal dose and timing of acquisition of GEH300079 (68Ga) PET/CT in the PC indication.
Phase 3
Phase 3 aims to demonstrate the safety and efficacy of GEH300079 (68Ga) PET/CT for the detection of PC in patients with confirmed colorectal, gastric or ovarian primary cancers.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GEH300079 (68Ga) Injection PET/CT
Trial Overview
The study tests GEH300079 (68Ga) Injection PET/CT's ability to detect PC in patients with certain types of cancer. It's a two-part study: Phase 2 confirms assumptions and optimal dose/timing; Phase 3 aims to prove safety and efficacy.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Single IV bolus of GEH300079 (68Ga), target activity 3.6 MBq/kg (150-300 MBq). PET/CT scan at 60 ±5 min post-dose (vertex to mid-thigh, \~20-30 min). Phase 2 subset: additional scans at 15 ±5 min and 3 h ±10 min.
Find a Clinic Near You
Who Is Running the Clinical Trial?
GE Healthcare
Lead Sponsor
Fotis Vlachos
GE Healthcare
Chief Marketing Officer since 2024
PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania
Peter J. Arduini
GE Healthcare
Chief Executive Officer since 2022
MBA from Northwestern University, BSc in Marketing from Susquehanna University
Fortrea
Industry Sponsor
Citations
Evaluation of 68Ga-FAPI PET/CT and 18F-FDG PET/CT for the ...
Ga-FAPI PET/CT improved the detection rate of recurrent colorectal cancers with negative 18F-FDG uptake. •. 68Ga-FAPI PET/CT was less ...
How does [68Ga]Ga-FAPI-46 PET/CT Transform Clinical ...
Finally, [68Ga]Ga-FAPI-46 PET/CT demonstrated a patient-based sensitivity of 100% (37/37) for detecting PM-CRC, compared to sensitivities of 92% ...
Diagnostic value of [68Ga]Ga-FAPI-04 in patients with ...
This study aimed to compare the diagnostic performance of [68Ga]Ga-FAPI-04 PET/CT and [18F]F-FDG PET/CT in primary and metastatic colorectal cancer (CRC) ...
[68Ga]Ga-GZP PET for Early Response Prediction in ...
This diagnostic study investigates the value of 68Ga-NOTA-GZP PET imaging in predicting and evaluating immunotherapy response in malignant tumors by ...
FDG PET/CT in the Management of Colorectal and Anal ...
Of the 41 patients studied, 25 (61.0%) had positive PET/CT results and 16 (39.0%) had negative PET/CT results. PET/CT had a high level of diagnostic efficacy (p ...
NCT07219238 | Study to Evaluate the Diagnostic ...
Phase 3 aims to demonstrate the safety and efficacy of GEH300079 (68Ga) PET/CT for the detection of PC in patients with confirmed colorectal, ...
Safety and Efficacy of 68Ga-DOTATATE PET/CT ...
No adverse events requiring treatment were observed. 68Ga-DOTATATE PET/CT changed treatment in 36% of participants. Given the lack of significant toxicity, ...
GEH300079 (68Ga) Injection Positron-Emission Tomography ...
Phase 3 aims to demonstrate the safety and efficacy of GEH300079 (68Ga) PET/CT for the detection of PC in patients with confirmed colorectal, ...
Evaluation of 68Ga-FAPI PET/CT and 18F-FDG ...
Ga-FAPI PET/CT improved the detection rate of recurrent colorectal cancers with negative 18F-FDG uptake. •. 68Ga-FAPI PET/CT was less physiologically absorbed ...
[68Ga]Ga-FAPI-46 PET accuracy for cancer imaging with ...
These results confirm the safety and potential of [68Ga]Ga-FAPI-46 PET as an imaging biomarker for the detection of FAP-expressing tumours.
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