Head and Neck CancerEarly Phase 1NCT07026981
[Ga-68]MTP220 PET for Biodistribution and Efficacy in Pancreatic Cancer and Head and Neck Cancers
A Early Phase 1 study testing [Ga-68]MTP220 PET/CT Scan in people with Head and Neck Cancer and Pancreatic Cancer, run by Qiubai Li at 1 site in United States.
Trial summary
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 (PaC). This tool is called a "targeted PET tracer", or more specifically a drug named "[Ga-68]MTP220". The U.S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Pancreatic Cancer, Cancer Pancreas
- What is being tested?
- [Ga-68]MTP220 PET/CT Scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2025to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants older than 18 years old
- Prior biopsy showing pancreatic or head and neck malignancy
- Participants have been newly diagnosed and not yet received definitive therapy (including surgery, radiation therapy, or systemic therapy).
- Able and willing to provide written informed consent before any protocol-specific procedures are undertaken
- Participants willing and able to undergo a PET/CT
Who cannot join
- Participants who do not meet the above mentioned inclusion criteria
- Participants with severe hepatic and renal dysfunction (Total bilirubin > 3 mg/dL, Albumin < 2.8 g/dL, INR > 2.3 (or prolonged PT), presence of ascites or hepatic encephalopathy (Grade III-IV) End-Stage Renal Disease (ESRD) or eGFR < 30 mL/min/1.73m², Serum creatinine > 4 mg/dL or rapidly rising, Need for dialysis (hemodialysis or peritoneal dialysis), uremic symptoms)
- Participants < 18 years old
- Participants who refuse to give or are unable to sign the informed consent
- Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks
- Participants unable to withstand or undergo PET/CT
- Pregnant or breast feeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Lauren Hahn
About this study
Official title: Exploratory, Prospective, Single-Arm, Open-labeled Study of [Ga68]MTP220 PET for First-in-Human Biodistribution and Efficacy in Patients With Pancreatic Cancer and Head and Neck Cancers
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 (PaC). This tool is called a "targeted PET tracer", or more specifically a drug named "[Ga-68]MTP220". The U.S. Food and Drug Administration (FDA) has not yet approved this drug, so researchers are conducting this research study to see if [Ga-68]MTP220 is safe and effective at diagnosing pancreatic cancer and head and neck cancer. FDA approval has been obtained for this study protocol by an Investigational New Drug (IND) application. Participants will receive a single injection of [Ga-68]MTP220 followed by PET/CT imaging at three points after they received the drug. These study procedures will take about 2.5 hours. Participants will also receive a follow-up phone call the day after receiving the drug to talk about any side effects they experienced.
Read the detailed description
For HNC, the overall 5-year survival rate of HNSCCs remains ∼40-50%. PaCa is the 3rd leading cause of cancer mortality in the US with its incidence expected to double by 2030. The poor survival of HNC and PaCa patients is partly due to the delayed diagnosis. Thus, early detection and diagnosis is pivotal to improve the survival. Currently, there is still an unmet clinical need for novel diagnostic technologies for early accurate detection and diagnosis of HNC and PaCa. In this exploratory first in human phase 0 trial, researchers are testing the use of a [Ga-68]MTP220 as a targeted PET tracer to explore the biodistribution, dosimetry, efficacy and safety in pancreatic and head and neck cancer patients.
- Conditions
- Head and Neck Cancer, Pancreatic Cancer, Cancer Pancreas
- Being tested
- [Ga-68]MTP220 PET/CT Scan
- Keywords
- [Ga68]MTP220, Positron Emission Tomography Computed Tomography, PET CT Scan
- Medical subject headings
- Head and Neck Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[Ga-68]MTP220 PET/CT ScanDrug
Participants will undergo PET/CT imaging after they have received an injection of the targeted PET tracer drug, [Ga-68]MTP220.
| Study group | Role | What they receive |
|---|---|---|
| [Ga-68]MTP220 PET/CT Imaging | Experimental | 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. Receives: Drug: [Ga-68]MTP220 PET/CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodistribution of [Ga-68]MTP220 in patients with pancreatic cancer and head and neck cancers, as measured by standardized uptake value (SUV) mean and maximum
Measured: Time it takes to do imaging study procedures, about 2.5 hours
Radiation dosimetry of [Ga-68]MTP220, as measured by dosimetry calculations performed using site software
Measured: Time it takes to do imaging study procedures, about 2.5 hours
Secondary outcomes (8)
Safety of [Ga-68]MTP220, as measured by number of participants who experience adverse events (AEs)
Measured: Participants will be asked to report AEs via telephone follow-up no more than 1 day after they undergo study imaging
Safety of [Ga-68]MTP220, as measured by number of participants who experience a significant change in blood pressure
Changes from baseline for vital signs may be tested for differences from zero by time point using ANOVA or paired t-test
Measured: Baseline (10 minutes before dose) and at the following points after they received the dose: 10, 50, 90, 140 minutes
Safety of [Ga-68]MTP220, as measured by number of participants who experience a significant change in heart rate
Changes from baseline for vital signs may be tested for differences from zero by time point using ANOVA or paired t-test
Measured: Baseline (10 minutes before dose) and at the following points after they received the dose: 10, 50, 90, 140 minutes
Safety of [Ga-68]MTP220, as measured by number of participants who experience a significant change in respiratory rate
Changes from baseline for vital signs may be tested for differences from zero by time point using ANOVA or paired t-test
Measured: Baseline (10 minutes before dose) and at the following points after they received the dose: 10, 50, 90, 140 minutes
Safety of [Ga-68]MTP220, as measured by number of participants who experience a significant change in blood oxygen saturation
Changes from baseline for vital signs may be tested for differences from zero by time point using ANOVA or paired t-test
Measured: Baseline (10 minutes before dose) and at the following points after they received the dose: 10, 50, 90, 140 minutes
Safety of [Ga-68]MTP220, as measured by number of participants who experience a significant change in electrocardiogram (ECG)
Changes in ECG will be summarized using descriptive statistics
Measured: Baseline (10 minutes before dose) and at the following points after the start of they received the dose: 10 and 140 minutes
Efficacy of [Ga-68]MTP220 PET/CT imaging in detecting PaCa or HNC, as measured by comparison of tumor vs normal tissue uptake of [Ga-68]MTP220, compared to conventional imaging (when available)
Uptake of [Ga-68]MTP-220 will be assessed by comparing lesion uptake to background activity
Measured: Time it takes to do imaging study procedures, about 2.5 hours
Potential of [Ga-68]MTP220 PET/CT for assessing tumor response to immunotherapy in PaCa and HNC, as measured by radiotracer uptake in tumors as compared to background activity, compared to conventional imaging (when available)
A tumor uptake that is low or approaching background levels-reflected by a low SUVmax is suggestive of a favorable treatment response. In contrast, persistently high uptake may indicate disease progression
Measured: Time it takes to do imaging study procedures, about 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study startSep 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qiubai Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qiubai Li, Case Comprehensive Cancer Center
- Investigators
- Qiubai Li, MD, Principal investigator, Case Comprehensive Cancer Center, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026981
- Sponsor's protocol ID
- CASE1Y25
- Status last verified
- Aug 2025
- First submitted
- 10 Jun 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory, Prospective, Single-Arm, Open-labeled Study of [Ga68]MTP220 PET for First-in-Human Biodistribution and Efficacy in Patients With Pancreatic Cancer and Head and Neck Cancers
- ClinicalTrials.gov ID
- NCT07026981
- Acronym / sponsor ID
- CASE1Y25
- Conditions
- Head and Neck Cancer, Pancreatic Cancer, Cancer Pancreas
- Keywords
- [Ga68]MTP220, Positron Emission Tomography Computed Tomography, PET CT Scan
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Qiubai LiUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (PaC). This tool is called a "targeted PET tracer", or more specifically a drug named "[Ga-68]MTP220". The U.S. Food and Drug Administration (FDA) has not yet approved this drug, so researchers are conducting this research study to see if [Ga-68]MTP220 is safe and effective at diagnosing pancreatic cancer and head and neck cancer. FDA approval has been obtained for this study protocol by an Investigational New Drug (IND) application. Participants will receive a single injection of [Ga-68]MTP220 followed by PET/CT imaging at three points after they received the drug. These study procedures will take about 2.5 hours. Participants will also receive a follow-up phone call the day after receiving the drug to talk about any side effects they experienced.
Detailed description
For HNC, the overall 5-year survival rate of HNSCCs remains ∼40-50%. PaCa is the 3rd leading cause of cancer mortality in the US with its incidence expected to double by 2030. The poor survival of HNC and PaCa patients is partly due to the delayed diagnosis. Thus, early detection and diagnosis is pivotal to improve the survival. Currently, there is still an unmet clinical need for novel diagnostic technologies for early accurate detection and diagnosis of HNC and PaCa. In this exploratory first in human phase 0 trial, researchers are testing the use of a [Ga-68]MTP220 as a targeted PET tracer to explore the biodistribution, dosimetry, efficacy and safety in pancreatic and head and neck cancer patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [Ga-68]MTP220 PET/CT Imaging | Experimental | Drug: [Ga-68]MTP220 PET/CT ScanParticipants 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants older than 18 years old
- Prior biopsy showing pancreatic or head and neck malignancy
- Participants have been newly diagnosed and not yet received definitive therapy (including surgery, radiation therapy, or systemic therapy).
- Able and willing to provide written informed consent before any protocol-specific procedures are undertaken
- Participants willing and able to undergo a PET/CT
Key exclusion criteria (7 listed)
- Participants who do not meet the above mentioned inclusion criteria
- Participants with severe hepatic and renal dysfunction (Total bilirubin > 3 mg/dL, Albumin < 2.8 g/dL, INR > 2.3 (or prolonged PT), presence of ascites or hepatic encephalopathy (Grade III-IV) End-Stage Renal Disease (ESRD) or eGFR < 30 mL/min/1.73m², Serum creatinine > 4 mg/dL or rapidly rising, Need for dialysis (hemodialysis or peritoneal dialysis), uremic symptoms)
- Participants < 18 years old
- Participants who refuse to give or are unable to sign the informed consent
- Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [Ga-68]MTP220 PET/CT ScanParticipants will undergo PET/CT imaging after they have received an injection of the targeted PET tracer drug, [Ga-68]MTP220. | Drug | [Ga-68]MTP220 PET/CT Imaging |
Primary outcome
Biodistribution of [Ga-68]MTP220 in patients with pancreatic cancer and head and neck cancers, as measured by standardized uptake value (SUV) mean and maximum
Time frame: Time it takes to do imaging study procedures, about 2.5 hours
Radiation dosimetry of [Ga-68]MTP220, as measured by dosimetry calculations performed using site software
Time frame: Time it takes to do imaging study procedures, about 2.5 hours
8 secondary outcomes
Safety of [Ga-68]MTP220, as measured by number of participants who experience adverse events (AEs)
Time frame: Participants will be asked to report AEs via telephone follow-up no more than 1 day after they undergo study imaging
Safety of [Ga-68]MTP220, as measured by number of participants who experience a significant change in blood pressure
Time frame: Baseline (10 minutes before dose) and at the following points after they received the dose: 10, 50, 90, 140 minutes
Safety of [Ga-68]MTP220, as measured by number of participants who experience a significant change in heart rate
Time frame: Baseline (10 minutes before dose) and at the following points after they received the dose: 10, 50, 90, 140 minutes
Safety of [Ga-68]MTP220, as measured by number of participants who experience a significant change in respiratory rate
Time frame: Baseline (10 minutes before dose) and at the following points after they received the dose: 10, 50, 90, 140 minutes
Safety of [Ga-68]MTP220, as measured by number of participants who experience a significant change in blood oxygen saturation
Time frame: Baseline (10 minutes before dose) and at the following points after they received the dose: 10, 50, 90, 140 minutes
Safety of [Ga-68]MTP220, as measured by number of participants who experience a significant change in electrocardiogram (ECG)
Time frame: Baseline (10 minutes before dose) and at the following points after the start of they received the dose: 10 and 140 minutes
Efficacy of [Ga-68]MTP220 PET/CT imaging in detecting PaCa or HNC, as measured by comparison of tumor vs normal tissue uptake of [Ga-68]MTP220, compared to conventional imaging (when available)
Time frame: Time it takes to do imaging study procedures, about 2.5 hours
Potential of [Ga-68]MTP220 PET/CT for assessing tumor response to immunotherapy in PaCa and HNC, as measured by radiotracer uptake in tumors as compared to background activity, compared to conventional imaging (when available)
Time frame: Time it takes to do imaging study procedures, about 2.5 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qiubai Li, MD principal investigator
Case Comprehensive Cancer Center, University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [Ga-68]MTP220 PET/CT Scan in people with Head and Neck Cancer and Pancreatic Cancer, run by Qiubai Li at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Hahn (216-844-9312, Lauren.Hahn@UHhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodistribution of [Ga-68]MTP220 in patients with pancreatic cancer and head and neck cancers, as measured by standardized uptake value (SUV) mean and maximum (time frame: Time it takes to do imaging study procedures, about 2.5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.