Upper Digestive Tract CancerPhase 2ERD2021NCT05214820
68Ga-PSMA PET Imaging of Upper Metastatic Gastric Cancers to Determine Eligibility to Endoradiotherapy
A Phase 2 study testing Radiopharmaceutical 68Ga-PSMA in people with Upper Digestive Tract Cancer, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 1 site in Canada.
Trial summary
Upper gastrointestinal (GI) cancers are a major health problem in Canada. At the metastatic stage, options are limited (usually chemotherapy, immunotherapy, personalized therapies under research protocols). These options are not applicable to all patients and may have significant toxicities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Digestive Tract Cancer
- What is being tested?
- Radiopharmaceutical 68Ga-PSMA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jan 2022to 31 Dec 2026
- Phase
- Phase 2
- 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
- Age 18 years and older
- Active cancer of the type adenocarcinoma (of the esophagus, of the stomach, of the bile ducts, or of the pancreas) documented by a CT scan performed within the last 8 weeks at the time of recruitment.
- An active cancer is defined as at least one lesion identified as stable or progressive neoplastic on CT imaging.
- A lesion treated with local therapy (e.g., external radiotherapy, cryoablation, radiofrequency ablation, resection) is not counted for inclusion criteria if this is done between the CT scan and the 68Ga-PSMA PET imaging. A lesion treated prior to the last CT scan may be considered eligible if progression is documented at the last CT scan.
- Able to provide free and informed consent.
- Feasibility to perform 68Ga-PSMA PET within 2 months of the CT scan that was used for inclusion.
Who cannot join
- Other active cancer (non-metastatic non-melanoma skin cancer excluded). Cancer in remission for at least 3 years will not be considered active.
- ECOG > 3.
- Pregnant woman.
- Unable to follow study rules.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Assessment of the Therapeutic Potential of 177Lu-PSMA Endoradiotherapy for the Treatment of Upper Metastatic Gastric Cancers Using 68Ga-PSMA PET-based Dosimetry
Upper gastrointestinal (GI) cancers are a major health problem in Canada. At the metastatic stage, options are limited (usually chemotherapy, immunotherapy, personalized therapies under research protocols). These options are not applicable to all patients and may have significant toxicities. Endoradiotherapy (ERT) using a radioisotope coupled with a localization vector specifically targeting tumor cells to deliver a localized dose of radiation therapy is a promising avenue as it can treat disseminated neoplastic disease in a specific manner sparing healthy tissue with minimal side effects. The main goal of this study is to confirm that patients with upper GI cancer would be eligible for ERT (177Lu-PSMA treatment by using 68Ga-PSMA PET/CT assessment).
Read the detailed description
Background: Upper gastrointestinal (GI) cancers are a major health problem in Canada. At the metastatic stage, options are limited (usually chemotherapy, immunotherapy, personalized therapies under research protocols). These options are not applicable to all patients and may have significant toxicities. Endoradiotherapy (ERT) using a radioisotope coupled with a localization vector specifically targeting tumor cells to deliver a localized dose of radiation therapy is a promising avenue as it can treat disseminated neoplastic disease in a specific manner sparing healthy tissue with minimal side effects.
177Lu-PSMA would be a potentially usable ERT agent for upper GI cancers. Initially developed for prostate cancer, for which it has been successfully proven, it targets the PSMA protein found on tumor cells or their microenvironment. Its localization is usually confirmed by imaging with 68Ga-PSMA, which is the other component of its theranostic pair.
There are many case reports showing significant accumulation of 68Ga-PSMA in upper GI cancers, but there are no prospective studies to determine with certainty whether these are isolated cases or whether these tumors consistently uptake this agent; the same uptake that determines whether 177Lu-PSMA ERT has potential efficacy for these patients.
We believe that 177Lu-PSMA ERT could provide an effective radiation dose to treat metastatic high-grade GI cancers without exceeding acceptable dose limits to healthy tissue, providing a new therapeutic avenue for this patient group.
Objective:
- To confirm that patients with upper gastric cancers would be eligible for 177Lu-PSMA treatment by using 68Ga-PSMA PET/CT assessment, according to the criteria suggested by the European Association of Nuclear Medicine (EANM) (tumor uptake 1.5 times higher than the liver)
- Determine tumor heterogeneity (proportion of tumor lesions identified by computed tomography (CT) that capture 68Ga-PSMA) in each patient;
- Determine the proportion of patients with lesions that do not accumulate 68Ga-PSMA;
- Calculate the pharmacokinetics of 68Ga-PSMA by serial PET imaging;
- Calculate dosimetry of healthy and tumor tissues;
Study population: Adults with upper metastatic gastric cancer (adenocarcinomas of the esophagus, stomach, bile ducts and pancreas)
Procedure and Follow-up: Patient will undergo 68Ga-PSMA PET imaging at different post-injection times (total visit duration of approximately half a day). Clinical data will be collected from this imaging and from the participant's medical record (demographic, treatment, medication, pathology, lab test results) for a 2-year follow-up period.
- Conditions
- Upper Digestive Tract Cancer
- Being tested
- Radiopharmaceutical 68Ga-PSMA
- Keywords
- Imaging, 68Ga-PSMA, Dosimetry, Positron emission tomography (PET)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiopharmaceutical 68Ga-PSMABiological
Injection of 68Ga-PSMA followed by 3 PET/CT acquisitions
| Study group | Role | What they receive |
|---|---|---|
| Single arm with 68Ga-PSMA | Experimental | All participants will undergo a PET scan with 68Ga-PSMA Receives: Biological: Radiopharmaceutical 68Ga-PSMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor uptake of 68Ga-PSMA
Proportion of participants with tumor uptake equal to or greater than 1.5 times the mean hepatic uptake (SUVmean) on 68Ga-PSMA PET according to the criteria suggested by the European Association of Nuclear Medicine (EANM)
Measured: At 1 hour post-injection acquisition
Secondary outcomes (4)
Tumor heterogeneity
Proportion of tumor lesions identified on CT that accumulate 68Ga-PSMA in each participant
Measured: At 1 hour post-injection acquisition
Tumor lesions that do not accumulate 68Ga-PSMA
Proportion of patients with CT-identified tumor lesions that do not accumulate 68Ga-PSMA
Measured: At 1 hour post-injection acquisition
Effective half-life of 68Ga-PSMA
Comparison of uptakes of 68Ga-PSMA in tumor lesions and healthy tissue at each time points
Measured: At 30 minutes, 60 minutes and, 120 minutes post-injection
Radiation dose (mGy)
Estimated radiation dose (mGy) delivered to healthy and tumor tissues from 177Lu-PSMA extrapolated from 68Ga-PSMA results
Measured: At 30 minutes, 60 minutes and120 minutes post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start17 Jan 2022
- Primary completion30 Dec 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 Upper Digestive Tract 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
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective pilot study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214820
- Sponsor's protocol ID
- 2022-4378
- Acronym
- ERD2021
- Status last verified
- May 2026
- First submitted
- 9 Dec 2021
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of the Therapeutic Potential of 177Lu-PSMA Endoradiotherapy for the Treatment of Upper Metastatic Gastric Cancers Using 68Ga-PSMA PET-based Dosimetry
- ClinicalTrials.gov ID
- NCT05214820
- Acronym / sponsor ID
- ERD2021 / 2022-4378
- Conditions
- Upper Digestive Tract Cancer
- Keywords
- Imaging, 68Ga-PSMA, Dosimetry, Positron emission tomography (PET)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de SherbrookeUniversity, hospital or other
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Jan 2022 (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.
Upper gastrointestinal (GI) cancers are a major health problem in Canada. At the metastatic stage, options are limited (usually chemotherapy, immunotherapy, personalized therapies under research protocols). These options are not applicable to all patients and may have significant toxicities. Endoradiotherapy (ERT) using a radioisotope coupled with a localization vector specifically targeting tumor cells to deliver a localized dose of radiation therapy is a promising avenue as it can treat disseminated neoplastic disease in a specific manner sparing healthy tissue with minimal side effects. The main goal of this study is to confirm that patients with upper GI cancer would be eligible for ERT (177Lu-PSMA treatment by using 68Ga-PSMA PET/CT assessment).
Detailed description
Background: Upper gastrointestinal (GI) cancers are a major health problem in Canada. At the metastatic stage, options are limited (usually chemotherapy, immunotherapy, personalized therapies under research protocols). These options are not applicable to all patients and may have significant toxicities. Endoradiotherapy (ERT) using a radioisotope coupled with a localization vector specifically targeting tumor cells to deliver a localized dose of radiation therapy is a promising avenue as it can treat disseminated neoplastic disease in a specific manner sparing healthy tissue with minimal side effects.
177Lu-PSMA would be a potentially usable ERT agent for upper GI cancers. Initially developed for prostate cancer, for which it has been successfully proven, it targets the PSMA protein found on tumor cells or their microenvironment. Its localization is usually confirmed by imaging with 68Ga-PSMA, which is the other component of its theranostic pair.
There are many case reports showing significant accumulation of 68Ga-PSMA in upper GI cancers, but there are no prospective studies to determine with certainty whether these are isolated cases or whether these tumors consistently uptake this agent; the same uptake that determines whether 177Lu-PSMA ERT has potential efficacy for these patients.
We believe that 177Lu-PSMA ERT could provide an effective radiation dose to treat metastatic high-grade GI cancers without exceeding acceptable dose limits to healthy tissue, providing a new therapeutic avenue for this patient group.
Objective:
- To confirm that patients with upper gastric cancers would be eligible for 177Lu-PSMA treatment by using 68Ga-PSMA PET/CT assessment, according to the criteria suggested by the European Association of Nuclear Medicine (EANM) (tumor uptake 1.5 times higher than the liver)
- Determine tumor heterogeneity (proportion of tumor lesions identified by computed tomography (CT) that capture 68Ga-PSMA) in each patient;
- Determine the proportion of patients with lesions that do not accumulate 68Ga-PSMA;
- Calculate the pharmacokinetics of 68Ga-PSMA by serial PET imaging;
- Calculate dosimetry of healthy and tumor tissues;
Study population: Adults with upper metastatic gastric cancer (adenocarcinomas of the esophagus, stomach, bile ducts and pancreas)
Procedure and Follow-up: Patient will undergo 68Ga-PSMA PET imaging at different post-injection times (total visit duration of approximately half a day). Clinical data will be collected from this imaging and from the participant's medical record (demographic, treatment, medication, pathology, lab test results) for a 2-year follow-up period.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective pilot study
| Arm | Type | Receives |
|---|---|---|
| Single arm with 68Ga-PSMA | Experimental | Biological: Radiopharmaceutical 68Ga-PSMAAll participants will undergo a PET scan with 68Ga-PSMA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years and older
- Active cancer of the type adenocarcinoma (of the esophagus, of the stomach, of the bile ducts, or of the pancreas) documented by a CT scan performed within the last 8 weeks at the time of recruitment.
- Able to provide free and informed consent.
- Feasibility to perform 68Ga-PSMA PET within 2 months of the CT scan that was used for inclusion.
Key exclusion criteria (4 listed)
- Other active cancer (non-metastatic non-melanoma skin cancer excluded). Cancer in remission for at least 3 years will not be considered active.
- ECOG > 3.
- Pregnant woman.
- Unable to follow study rules.
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 |
|---|---|---|
| Radiopharmaceutical 68Ga-PSMAInjection of 68Ga-PSMA followed by 3 PET/CT acquisitions | Biological | Single arm with 68Ga-PSMA |
Primary outcome
Tumor uptake of 68Ga-PSMA
Time frame: At 1 hour post-injection acquisition
Proportion of participants with tumor uptake equal to or greater than 1.5 times the mean hepatic uptake (SUVmean) on 68Ga-PSMA PET according to the criteria suggested by the European Association of Nuclear Medicine (EANM)
4 secondary outcomes
Tumor heterogeneity
Time frame: At 1 hour post-injection acquisition
Tumor lesions that do not accumulate 68Ga-PSMA
Time frame: At 1 hour post-injection acquisition
Effective half-life of 68Ga-PSMA
Time frame: At 30 minutes, 60 minutes and, 120 minutes post-injection
Radiation dose (mGy)
Time frame: At 30 minutes, 60 minutes and120 minutes post-injection
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 28 May 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiopharmaceutical 68Ga-PSMA in people with Upper Digestive Tract Cancer, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 1 site in Canada.
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 6 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. 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 Canada. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor uptake of 68Ga-PSMA (time frame: At 1 hour post-injection acquisition). 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 28 May 2026.