VGT-309 Imaging Technique for Colorectal Cancer

Overseen By Marissa N Dobry

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Stanford University

Disqualifiers: Pregnancy, Allergy to ICG, Long QT, Obesity, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 18 days

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging technique, VGT-309 (also known as Abenacianine), to determine if it can safely and effectively aid doctors in visualizing colorectal cancer during standard colonoscopy procedures. By using near-infrared fluorescence, the technique aims to enhance tumor visibility and improve detection. Individuals with confirmed distal colorectal cancer, scheduled for a colonoscopy following treatments like radiochemotherapy, might be suitable candidates for this study. Participants will receive an IV infusion of the experimental treatment before their scheduled colonoscopy. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to experience this innovative approach.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the VGT-309 imaging technique is safe for colorectal cancer visualization?

Research has shown that VGT-309 is generally safe and well-tolerated. Earlier studies found that patients who took VGT-309 did not experience major side effects. Specifically, safety data from studies using VGT-309 for other purposes suggested it can help visualize tumors without harming patients. These findings support the safety of VGT-309 for humans, although further research is underway to confirm this. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about VGT-309 because it offers a new imaging technique for colorectal cancer that could enhance detection and diagnosis. Unlike traditional imaging methods like CT scans or MRIs, VGT-309 is administered intravenously and designed to work in conjunction with endoscopy procedures, potentially improving visualization of cancerous tissues. This targeted approach could lead to more precise identification of tumors, allowing for better treatment planning and improved patient outcomes.

What evidence suggests that the VGT-309 imaging technique is effective for colorectal cancer?

Research shows that VGT-309, which participants in this trial will receive, could help identify cancerous tumors. Previous studies demonstrated that VGT-309 is safe and effective in highlighting tumors during lung cancer surgeries, aiding doctors in visibility. Although less information exists on its use for colorectal cancer, the method with VGT-309 has improved tumor detection in similar cases. This treatment uses near-infrared (NIR) light, enabling real-time tumor visualization. These early findings suggest that VGT-309 may assist doctors in locating colorectal tumors more easily. ^{1 3 4 6 7}

Who Is on the Research Team?

Stephan Rogalla, M.D., PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

Adults with confirmed colorectal adenocarcinoma who are scheduled for a standard colonoscopy can join. They must have good liver and kidney function, not be pregnant or breastfeeding, agree to use effective contraception, and have an ECOG score of 0-2. Those allergic to ICG or VGT-309 components, with certain heart conditions, or unable to consent cannot participate.

Inclusion Criteria

I am a man who will use effective birth control if my partner can get pregnant.

I am scheduled for a colonoscopy in the operating room before surgery or for restaging after treatment.

My kidney and liver are functioning well.

Exclusion Criteria

You are allergic to ICG or other contrast agents used in medical imaging.

I have a long QT syndrome or my heart's electrical cycle is longer than normal.

Pregnant or breastfeeding females

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an IV infusion of 0.32 mg/kg VGT-309 12 to 36 hours before a standard of care endoscopy procedure

18 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VGT-309

Trial Overview The trial is testing the safety and effectiveness of VGT-309 as a fluorescent probe during augmented colonoscopy for real-time visualization of colorectal tumors using NIR fluorescence endoscopy. It also examines over 50 biomarkers in biopsies.

How Is the Trial Designed?

Group I: VGT-309 Experimental Treatment 1 Intervention

Subjects will receive an IV infusion of 0.32 mg/kg VGT-309 12 to 36 hours before a standard of care endoscopy procedure.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Stephan Rogalla

Lead Sponsor

Stanford's Innovative Medicines Accelerator

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

In a clinical trial involving 28 scanning examinations, 67Gallium-citrate provided superior tumor imaging quality and better correlation with known disease sites compared to 111Indium-bleomycin, with no cases where 111Indium-bleomycin was found to be superior.

Biopsy analysis showed that while 67Gallium-citrate was more effective in detecting tumors in lymph nodes, its performance varied in spleen samples, indicating that 67Gallium-citrate is generally more useful for imaging tumors above the diaphragm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical comparison of the tumour-imaging radiopharmaceuticals 67Gallium-citrate and 111Indium-labelled bleomycin. Paterson, AH., Taylor, DM., McCready, VR.[2015]

In a study of 27 colorectal carcinoma cases, 67Ga-scintigraphy successfully detected lesions in 63% of preoperative scans, indicating its potential as a useful imaging tool for identifying colorectal cancer before surgery.

All lesions were confirmed in the resected specimens, suggesting that 67Ga-citrate accumulates in colorectal carcinoma, which may enhance the accuracy of cancer detection with improved imaging techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[67Ga-scintigraphic finding of colorectal carcinoma; the basis of clinicopathologic viewpoint]. Sumi, Y., Ozaki, Y., Amemiya, K., et al.[2016]

A study involving 20 patients with suspected recurrent colorectal cancer found no significant difference in tumor detection between two different doses of the radiopharmaceutical 111In-B72.3 (80 MBq vs. 150 MBq), suggesting that the higher dose may not be necessary for effective imaging.

While higher doses did not improve overall tumor detection, advanced imaging techniques like orthogonal and 3D SPET provided valuable confirmation of tumor sites, although caution is needed due to potential false-positive results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Planar, SPET and three-dimensional immunoscintigraphy of suspected recurrent colorectal cancer using 111In-B72.3 (Oncoscint CR-OV): effect of administered activity. Perkins, AC., Vincent, RM., Wastie, ML., et al.[2019]

Activated charcoal labeled with Gallium-67 citrate shows good stability in vitro, maintaining over 91% labeling efficiency for up to 96 hours at physiological pH levels, making it a promising alternative for colonic transit studies.

In vivo testing with five volunteers demonstrated that the Gallium-67 activated charcoal capsules effectively disintegrated in the colon, allowing for clear detection of radioactivity, which is crucial for assessing colonic transit time, especially in constipated patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gallium-67 activated charcoal: a new method for preparation of radioactive capsules for colonic transit study. Cheng, KY., Tsai, SC., Lin, WY.[2018]

Positron emission tomography (PET) with fluorine-18 fluorodeoxyglucose (FDG) demonstrated a 100% sensitivity in detecting known intraluminal colorectal carcinomas in 37 patients, making it a highly effective diagnostic tool for primary colorectal cancer.

FDG PET was superior to computed tomography (CT) in identifying liver metastases, showing an 88% sensitivity compared to CT's 38%, indicating its enhanced capability in staging colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Staging of primary colorectal carcinomas with fluorine-18 fluorodeoxyglucose whole-body PET: correlation with histopathologic and CT findings. Abdel-Nabi, H., Doerr, RJ., Lamonica, DM., et al.[2022]

Over the past decade, survival rates for colorectal cancer patients have significantly improved due to advancements in imaging technology, surgical techniques, and personalized treatment options, including new chemotherapy drugs.

Functional imaging techniques, such as positron emission tomography (PET) and emerging methods like dynamic contrast-enhanced MRI, are becoming increasingly important in the clinical management of colorectal cancer, complementing traditional imaging approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional imaging of colorectal cancer: positron emission tomography, magnetic resonance imaging, and computed tomography. Kapse, N., Goh, V.[2019]

In a study of 24 patients with colorectal cancer, the immunoscintigraphic technique using technetium-99m labeled monoclonal antibody 88BV59 detected approximately 25% more lesions than traditional CT scans, highlighting its potential for improved cancer detection.

The antibody scan demonstrated a sensitivity of 68% for detecting extrahepatic disease, significantly higher than the 41% sensitivity of CT, suggesting that this method may be more effective in identifying metastatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human monoclonal antibody 99mTc-88BV59: detection of colorectal cancer, recurrent or metastatic disease and immunogenicity assessment. Krause, BJ., Baum, RP., Staib-Sebler, E., et al.[2020]

In a study of 33 colorectal cancer patients in complete remission, the combined use of FDG-PET and contrast-enhanced CT (FDG-PET/ceCT) significantly improved the detection of cancer recurrence, achieving a sensitivity of 97% in identifying lesions.

While both FDG-PET and ceCT showed similar effectiveness in patient-based analyses, the combination of the two techniques provided better accuracy for detecting specific lesions, highlighting the importance of using both methods for surveillance in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

¹⁸F-FDG PET/contrast enhanced CT in the standard surveillance of high risk colorectal cancer patients. Jiménez Londoño, GA., García Vicente, AM., Sánchez Pérez, V., et al.[2017]

CB-FDG imaging demonstrated high sensitivity (95%) and specificity (81%) for detecting recurrent colorectal cancer, outperforming conventional computed tomography (CT) which had a sensitivity of 88% and specificity of 64%.

The use of CB-FDG significantly influenced treatment decisions, with 54% of oncologists and 28% of surgeons changing their recommended approaches based on CB-FDG findings, highlighting its clinical value in staging and treatment selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical impact of camera-based positron emission tomography imaging in patients with recurrent colorectal cancer. Miller, E., Lerman, H., Gutman, M., et al.[2016]

Carcinoid tumors have a high presence of somatostatin receptors, making them particularly suitable for imaging with 68Ga-DOTATATE, which can help in the initial staging and monitoring of these tumors.

In a specific case, a patient exhibited strong uptake of 68Ga-DOTATATE while showing low uptake of F18-FDG, highlighting the potential of 68Ga-DOTATATE for better detection of carcinoid tumors compared to traditional imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is 68Ga-DOTATATE the answer in lung carcinoid? : Case report and review of literature. Bhoil, A., Mittal, BR., Gayana, S., et al.[2021]

In a study of 102 patients with potentially resectable metastatic colorectal cancer, FDG PET-CT significantly impacted management decisions for 30% of patients by clarifying indeterminate lesions and detecting previously unknown metastases.

The use of FDG PET-CT led to 36 patients being deemed ineligible for surgery, preventing 16 unnecessary surgeries, while also aiding in the identification of patients who could benefit from potentially curative metastatic surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of FDG PET-CT in patients with potentially operable metastatic colorectal cancer. Briggs, RH., Chowdhury, FU., Lodge, JP., et al.[2016]

Immunoscintigraphy using CYT-103, an 111indium-labelled immunoconjugate, showed high sensitivity and specificity in detecting primary and metastatic colorectal cancer lesions, identifying 12 out of 15 malignant sites compared to 9 detected by CT.

There were no adverse reactions reported from the administration of CYT-103, indicating its safety for use in patients prior to surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunoscintigraphy of primary colorectal cancers with indium-111 monoclonal antibody B72.3. Joypaul, BV., Kennedy, N., Hanson, J., et al.[2016]

The modified vasoactive intestinal peptide (TP 3654) labeled with 99mTc showed rapid clearance from the body, with 70% eliminated through the kidneys and 20% through the liver, indicating a favorable pharmacokinetic profile for imaging.

In a study involving 11 cancer patients, the 99mTc-TP 3654 scan successfully identified tumors expressing VIP receptors within 20 minutes, demonstrating its potential efficacy in tumor imaging compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

99mTc-labeled vasoactive intestinal peptide analog for rapid localization of tumors in humans. Thakur, ML., Marcus, CS., Saeed, S., et al.[2016]

Citations

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Phase 2 multicenter clinical trial to evaluate the safety and ... Phase 2 multicenter clinical trial to evaluate the safety and efficacy of abenacianine for injection (VGT-309), a tumor-targeted, intraoperative ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12513740/

Phase 2 Dose-Ranging Trial of VGT-309 for Molecular ... Results support the safety and efficacy of VGT-309 in identifying cancer in the lung with 0.16 mg/kg day-before surgery dosing and 0.32 mg/kg at ...

3. vergentbio.com vergentbio.com/clinical-summary

Clinical Summary | Vergent Bioscience | Tumor Visualization Phase 1 and 2 clinical studies have yielded compelling data that suggest VGT-309 is safe and well-tolerated, and labels human lung tumors during resection ...

4. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2025.43.16_suppl.3069

Phase 2 multicenter clinical trial to evaluate the safety and ... Phase 2 multicenter clinical trial to evaluate the safety and efficacy of abenacianine for injection (VGT-309), a tumor-targeted, intraoperative ...

5. withpower.com withpower.com/trial/early-phase-1-colorectal-neoplasms-8-2023-dfd17

VGT-309 Imaging Technique for Colorectal Cancer The available research shows that imaging techniques like FDG-PET and PET-CT have improved the detection and management of colorectal cancer. These techniques ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06034197

Fluorescent Probe VGT-309 to ID Cancerous Colorectal ... The purpose of this study is to determine the safety and feasibility of VGT-309 for the visualization of colorectal tumors in real-time using near-infrared (NIR) ...

7. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/f/NCT06034197.html

Fluorescent Probe VGT-309 to ID Cancerous Colorectal ... The purpose of this study is to determine the safety and feasibility of VGT-309 for the visualization of colorectal tumors in real-time using near-infrared ...