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

Trial Summary

What is the purpose of this trial?

This trial is testing a new substance called VGT-309 that helps doctors see colorectal tumors better during an endoscopy by making them glow under a special light. It targets patients with colorectal tumors to improve detection. The study also looks at various biomarkers in tumor samples.

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 data supports the idea that VGT-309 Imaging Technique for Colorectal Cancer (also known as: VGT-309, Abenacianine) is an effective treatment?

The available research shows that imaging techniques like FDG-PET and PET-CT have improved the detection and management of colorectal cancer. These techniques help in accurately identifying cancer recurrence and staging, which are crucial for effective treatment planning. Although the studies do not specifically mention VGT-309, they highlight the importance of advanced imaging in improving patient outcomes. This suggests that VGT-309, as an imaging technique, could be effective in similar ways by providing detailed insights into the cancer's status, aiding in better treatment decisions. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment VGT-309, Abenacianine, for colorectal cancer?

The research highlights the effectiveness of imaging techniques like PET-CT in detecting and managing colorectal cancer, which can improve treatment outcomes. While not directly about VGT-309, these imaging advancements help in better staging and monitoring, potentially enhancing the effectiveness of treatments like VGT-309. ^{1 2 3 4 5}

What safety data exists for VGT-309 or Abenacianine?

The research does not provide specific safety data for VGT-309 or Abenacianine. However, a study involving a similar imaging agent, 99mTc-labeled vasoactive intestinal peptide analog (TP 3654), reported no adverse reactions in 3 healthy volunteers and 11 cancer patients. This suggests a favorable safety profile for similar imaging agents, but direct data for VGT-309 or Abenacianine is not available in the provided research. ^{6 7 8 9 10}

Is VGT-309 (Abenacianine) safe for use in humans?

In a study involving 3 healthy volunteers and 11 cancer patients, no adverse reactions were noted after the injection of a similar imaging agent, 99mTc-TP 3654, which is used for tumor imaging. ^{6 7 8 9 10}

Is the treatment in the VGT-309 Imaging Technique for Colorectal Cancer a promising treatment?

Yes, the treatment is promising because it uses advanced imaging techniques that can detect more cancer lesions than traditional methods like CT scans. This means it could help doctors find and treat colorectal cancer more effectively. ^{7 9 11 12 13}

How does the VGT-309 imaging technique for colorectal cancer differ from other treatments?

The VGT-309 imaging technique for colorectal cancer is unique because it likely involves a novel imaging agent or method that enhances the detection of cancerous lesions, potentially offering better accuracy or sensitivity compared to existing imaging techniques like CT or traditional radiopharmaceuticals. ^{7 9 11 12 13}

Research Team

Stephan Rogalla, M.D., PhD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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 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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

¹⁸F-FDG PET/contrast enhanced CT in the standard surveillance of high risk colorectal cancer patients. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Staging of primary colorectal carcinomas with fluorine-18 fluorodeoxyglucose whole-body PET: correlation with histopathologic and CT findings. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The clinical impact of camera-based positron emission tomography imaging in patients with recurrent colorectal cancer. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Clinical impact of FDG PET-CT in patients with potentially operable metastatic colorectal cancer. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

99mTc-labeled vasoactive intestinal peptide analog for rapid localization of tumors in humans. [2016]

7. England 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. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Gallium-67 activated charcoal: a new method for preparation of radioactive capsules for colonic transit study. [2018]

9. England pubmed.ncbi.nlm.nih.gov

A clinical comparison of the tumour-imaging radiopharmaceuticals 67Gallium-citrate and 111Indium-labelled bleomycin. [2015]

10. India pubmed.ncbi.nlm.nih.gov

Is 68Ga-DOTATATE the answer in lung carcinoid? : Case report and review of literature. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

Human monoclonal antibody 99mTc-88BV59: detection of colorectal cancer, recurrent or metastatic disease and immunogenicity assessment. [2020]

12. Scotland pubmed.ncbi.nlm.nih.gov

Immunoscintigraphy of primary colorectal cancers with indium-111 monoclonal antibody B72.3. [2016]

13. Japan pubmed.ncbi.nlm.nih.gov

[67Ga-scintigraphic finding of colorectal carcinoma; the basis of clinicopathologic viewpoint]. [2016]