GEH300079 PET/CT for Colorectal Cancer

Not yet recruiting at 1 trial location

Overseen By Michelle Straszacker

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: GE Healthcare

Must not be taking: Antibacterials, Antivirals, Antifungals

Disqualifiers: Pregnancy, Renal impairment, Hepatic impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

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. ^{1 2 3 4 5}

Why 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. ^{6 7 8 9 10}

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

Participant has provided signed informed consent before any study-specific screening procedures

Participant is able and willing to comply with all study procedures as described in the protocol

My cancer is confirmed to be colorectal, gastric, ovarian, or pancreatic.

Exclusion Criteria

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 (IMP)

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

Single time point

Multiple imaging sessions

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.

Single time point

Multiple imaging sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: GEH300079 (68Ga) PET/CT Injection Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

GE Healthcare

Lead Sponsor

Trials

307

Recruited

634,000+

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

Trials

22

Recruited

5,800+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11405641/

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 ...

2. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251655

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% ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9869033/

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) ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06982053

[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 ...

5. ajronline.org ajronline.org/doi/10.2214/AJR.13.12256

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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07219238

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, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5362940/

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, ...

8. ichgcp.net ichgcp.net/clinical-trials-registry/NCT07219238

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, ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2405630824001253

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 ...

10. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(25)00299-2/fulltext

[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.