[Ga-68]MTP220 PET for Cancer

Overseen By Lauren Hahn

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Qiubai Li

Must not be taking: Chemotherapy, Radiation therapy

Disqualifiers: Severe hepatic, renal dysfunction, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new diagnostic tool for detecting head and neck cancer and pancreatic cancer. The tool uses a targeted PET tracer, called [Ga-68]MTP220, injected into the body to enhance cancer visibility during scans. Researchers aim to determine the tool's safety and effectiveness. Individuals newly diagnosed with head and neck or pancreatic cancer, who have not yet begun treatment, may qualify for this trial. As an Early Phase 1 trial, this research seeks to understand how the new diagnostic tool functions in people, offering participants the chance to be among the first to benefit from this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have had anti-cancer treatment in the last 2 weeks, you cannot participate.

What prior data suggests that this diagnostic tool is safe for humans?

Research has shown that PET/CT scans using Gallium-68 (Ga-68) tracers, such as [Ga-68]MTP220, are generally safe and well-tolerated by patients. Studies with similar Ga-68 tracers have found that these imaging agents usually do not cause significant side effects and expose patients to less radiation than other methods, making them relatively safe for imaging procedures. In this trial, participants will receive one injection of [Ga-68]MTP220, followed by a scan. The trial emphasizes safety, particularly since it is in the early stages. Participants will be closely monitored for any side effects, providing an extra layer of safety. While specific data for [Ga-68]MTP220 is not yet available, similar tracers have demonstrated a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about [Ga-68]MTP220 PET/CT imaging because it offers a new way to visualize cancerous tissues in the body. Unlike traditional imaging methods, which might not be as specific or detailed, [Ga-68]MTP220 uses a radiotracer that targets cancer cells with high precision. This allows for clearer and more accurate PET/CT scans, potentially leading to earlier and more accurate diagnosis of cancers. Additionally, the imaging is done relatively quickly after the injection, capturing detailed images at multiple time points, which could improve the understanding of how cancer behaves in the body.

What evidence suggests that this diagnostic tool is effective for detecting head and neck cancer and pancreatic cancer?

Research has shown that similar Gallium-68 PET/CT scans have been promising in diagnosing other cancers. Studies have found that these scans can accurately identify and assess the stage of prostate cancer, aiding doctors in planning the best treatment. This imaging has also successfully detected neuroendocrine tumors, another type of cancer. In this trial, participants will receive [Ga-68]MTP220 PET/CT imaging to evaluate its effectiveness in identifying head and neck cancer and pancreatic cancer. Although it is still early, the potential for this imaging to enhance cancer detection appears promising. ^{2 3 4 6 7}

Who Is on the Research Team?

Qiubai Li, MD

Principal Investigator

Case Comprehensive Cancer Center, University Hospitals

Are You a Good Fit for This Trial?

This trial is for individuals with head and neck cancer or pancreatic cancer. Participants will receive a new diagnostic drug, [Ga-68]MTP220, to see if it's effective in detecting these cancers. The FDA has approved the study protocol.

Inclusion Criteria

Able and willing to provide written informed consent before any protocol-specific procedures are undertaken

I am over 18 years old.

I had a biopsy confirming cancer in my pancreas or head/neck.

Exclusion Criteria

I do not have severe liver or kidney problems.

I am under 18 years old.

Participants unable to withstand or undergo PET/CT

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single injection of [Ga-68]MTP220 followed by PET/CT imaging at three points after the injection

1 day

1 visit (in-person)

Follow-up

Participants receive a follow-up phone call the day after receiving the drug to discuss any side effects

1 day

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• [Ga-68]MTP220

Trial Overview [Ga-68]MTP220 PET/CT Scan is being tested as a diagnostic tool for head and neck and pancreatic cancers. Patients will get an injection of the drug followed by PET/CT scans at different times over approximately 2.5 hours.

How Is the Trial Designed?

Group I: [Ga-68]MTP220 PET/CT Imaging Experimental Treatment 1 Intervention

Participants will receive an injection of 210 MBq (3.0-6.0 mCi, range 110-220 MBq with an upper limit of 220 MBq) of \[Ga68\]MTP220 by slow IV push. This will be followed by PET/CT imaging. One diagnostic CT scan will be performed followed by a sequential whole body PET scan (including 7 to 8 fields-of-view depending on participant height) at three points after the injection of the drug. These three points will be 20, 60 and 100 minutes after the injection. Imaging will be performed for about 1 minute per bed position. The total duration of PET data acquisition is about 20-30 minutes.

Who Is Running the Clinical Trial?

Qiubai Li

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8322807/

Performance of Ga-68 PSMA PET/CT for diagnosis and ... This trial provides early evidence that PSMA PET/CT assists in the grading of prostate cancer and suggests that the imaging modality is particularly accurate ...

2. trial.medpath.com trial.medpath.com/clinical-trial/fe7f51fd2b7113e6/nct07026981-ga68-mtp220-pet-pancreatic-cancer-head-neck-cancer

[Ga-68]MTP220 PET for Biodistribution and Efficacy ... - MedPath The goal of this research study is to develop a diagnostic tool to help with detection and diagnosis of head and neck cancer (HNC) and pancreatic cancer ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03822845

Evaluating the Clinical Accuracy of Gallium-68 PSMA PET ... This study investigates if a new drug (PSMA) makes prostate cancer easier to identify in positron-emission tomography (PET) imaging.

4. netrf.org netrf.org/2018/11/13/gallium-68-scan-for-neuroendocrine-tumors/

Ga-68 Dotatate PET/CT Scan for Neuroendocrine Tumors The Ga-68 PET/CT full-body scan can capture neuroendocrine tumors (NETs) that overexpress somatostatin receptors and show where the tumors are in the body.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5871999/

Review of Gallium-68 PSMA PET/CT Imaging in the ... 68 Ga-PSMA PET/CT has the ability to reliably stage prostate cancer at presentation and can help inform an optimal treatment approach.

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

Safety and Efficacy of 68Ga-DOTATATE PET/CT ... Ga-DOTATATE PET/CT changed treatment in 36% of participants. Given the lack of significant toxicity, lower radiation exposure, and improved accuracy compared ...

7. mirt.tsnmjournals.org mirt.tsnmjournals.org/articles/performance-of-lesssupgreater68lesssupgreaterga-psma-petct-in-metastatic-prostate-cancers-at-the-time-of-diagnosis-and-correlation-with-obesity/mirt.galenos.2025.46762

Performance of 68Ga-PSMA PET/CT in Metastatic Prostate ... Ga-PSMA PET/CT is the most sensitive imaging modality for staging prostate cancer, especially in patients classified as intermediate to high risk. The majority ...