Adenoid Cystic CarcinomaEarly Phase 1NCT04801264
Diagnosis of Adenoid Cystic Carcinoma on 68Ga-PSMA-617 PET-CT and Therapy With 177Lu-EB-PSMA-617
A Early Phase 1 study testing 68Ga-PSMA and 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617 in people with Adenoid Cystic Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Adenoid cystic carcinoma (ACC) accounts for 24% of salivary gland malignant tumors, is characterized by frequent local recurrences and distant metastasis, mainly to lungs. Considering its origination from salivary glands, an organ with intense physiological uptake of 68Ga-PSMA-617, this study aims to evaluate… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adenoid Cystic Carcinoma
- What is being tested?
- 68Ga-PSMA and 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 31 Dec 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed treated or untreated adenoid cystic carcinoma patients;
- 18F-FDG PET/CT within two weeks;
- signed written consent.
Who cannot join
- pregnancy;
- breastfeeding;
- known allergy against PSMA
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Zhaohui Zhu, MD, 86-13611093752, 13611093752@163.com
Guochang Wang, MD, 86-18516822732, guochang1007@163.com
About this study
Adenoid cystic carcinoma (ACC) accounts for 24% of salivary gland malignant tumors, is characterized by frequent local recurrences and distant metastasis, mainly to lungs. Considering its origination from salivary glands, an organ with intense physiological uptake of 68Ga-PSMA-617, this study aims to evaluate 68Ga-PSMA-617 uptake in local recurrent or metastatic ACC in comparison with 18F-FDG uptake in the same patients, and assess the feasibility of 177Lu-EB-PSMA-617 treatment in patients with the advanced ACC.
Read the detailed description
Adenoid cystic carcinoma (ACC) is a rare tumor entity with a yearly incidence of 3-5 cases per million. ACC arises in the major salivary glands and more often in the minor salivary glands of the oropharynx, lip, nasopharynx, oral cavity, nasal cavity, paranasal sinus, larynx and tracheobronchial tree. ACC is characterized by frequent local recurrences and distant metastasis, mainly to lungs. 18F-FDG PET/CT is considered to be a viable tool to assess ACC at initial presentation. However, FDG uptake in ACC is lower than in squamous cell carcinoma (SCC) and not all ACC lesions show detectable FDG uptake. So, it is necessary to find another effective way to detect ACC and its metastases. As in known, PSMA is highly expressed in salivary glands, and Wim van Boxtel et al had demonstrated high PSMA-ligand uptake in a patient with recurrent and metastatic ACC using 68Ga-PSMA PET/CT. 68Ga-PSMA has been developed as a targeting imaging agent widely used in prostate cancer in prostate cancer. Thus, this prospective study is going to investigate whether 68Ga-PSMA PET/CT may be superior for diagnosis, therapy response assessment and follow-up of ACC than 18F-FDG PET/CT. Furthermore, peptide receptor radionuclide therapy has been widely used in the treatment of prostate cancer lesions that showed high PSMA uptake on 68Ga-PSMA PET/CT, we'll try to assess the safety and therapeutic response to 177Lu-EB-PSMA-617 in patients with ACC.
- Conditions
- Adenoid Cystic Carcinoma
- Being tested
- 68Ga-PSMA, 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617
- Medical subject headings
- Carcinoma, Adenoid Cystic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-PSMADrug
Also called 68Ga-prostate specific membrane antigen
Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-PSMA. Tracer doses of 68Ga-PSMA will be used to image lesions of adenoid cystic carcinoma by PET/CT.
1.85GBq (50 mCi) of 177Lu-EB-PSMA-617Drug
Patients were intravenous injected with the dose about 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-PSMA, PET/CT and 177Lu-EB-PSMA-617 therapy | Experimental | All patients diagnosed with ACC underwent 68Ga-PSMA PET/CT scan. If the PET/CT showed high PSMA expression in tumor lesions of some patients, they would intravenously injected with the dose about 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617 for therapy. Receives: Drug: 68Ga-PSMA; Drug: 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value
Sensitivity and Specificity of 68Ga-PSMA PET/CT for adenoid cystic carcinoma in comparison with 18F-FDG PET/CT
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Safety of therapy
the safety assessed by CTCAE v4.0
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Sep 2020
- Primary completion1 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenoid Cystic CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhaohui Zhu, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801264
- Sponsor's protocol ID
- PekingUMCHPSMAACC
- Status last verified
- Mar 2021
- First submitted
- 23 Feb 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang G, Zhou M, Zang J, Jiang Y, Chen X, Zhu Z, Chen X. A pilot study of 68 Ga-PSMA-617 PET/CT imaging and 177Lu-EB-PSMA-617 radioligand therapy in patients with adenoid cystic carcinoma. EJNMMI Res. 2022 Aug 19;12(1):52. doi: 10.1186/s13550-022-00922-x.
PubMed 35984529
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Adenoid Cystic Carcinoma on 68Ga-PSMA-617 PET-CT and Therapy With 177Lu-EB-PSMA-617
- ClinicalTrials.gov ID
- NCT04801264
- Acronym / sponsor ID
- PekingUMCHPSMAACC
- Conditions
- Adenoid Cystic Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 16 Mar 2021 (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.
Adenoid cystic carcinoma (ACC) accounts for 24% of salivary gland malignant tumors, is characterized by frequent local recurrences and distant metastasis, mainly to lungs. Considering its origination from salivary glands, an organ with intense physiological uptake of 68Ga-PSMA-617, this study aims to evaluate 68Ga-PSMA-617 uptake in local recurrent or metastatic ACC in comparison with 18F-FDG uptake in the same patients, and assess the feasibility of 177Lu-EB-PSMA-617 treatment in patients with the advanced ACC.
Detailed description
Adenoid cystic carcinoma (ACC) is a rare tumor entity with a yearly incidence of 3-5 cases per million. ACC arises in the major salivary glands and more often in the minor salivary glands of the oropharynx, lip, nasopharynx, oral cavity, nasal cavity, paranasal sinus, larynx and tracheobronchial tree. ACC is characterized by frequent local recurrences and distant metastasis, mainly to lungs. 18F-FDG PET/CT is considered to be a viable tool to assess ACC at initial presentation. However, FDG uptake in ACC is lower than in squamous cell carcinoma (SCC) and not all ACC lesions show detectable FDG uptake. So, it is necessary to find another effective way to detect ACC and its metastases. As in known, PSMA is highly expressed in salivary glands, and Wim van Boxtel et al had demonstrated high PSMA-ligand uptake in a patient with recurrent and metastatic ACC using 68Ga-PSMA PET/CT. 68Ga-PSMA has been developed as a targeting imaging agent widely used in prostate cancer in prostate cancer. Thus, this prospective study is going to investigate whether 68Ga-PSMA PET/CT may be superior for diagnosis, therapy response assessment and follow-up of ACC than 18F-FDG PET/CT. Furthermore, peptide receptor radionuclide therapy has been widely used in the treatment of prostate cancer lesions that showed high PSMA uptake on 68Ga-PSMA PET/CT, we'll try to assess the safety and therapeutic response to 177Lu-EB-PSMA-617 in patients with ACC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-PSMA, PET/CT and 177Lu-EB-PSMA-617 therapy | Experimental | Drug: 68Ga-PSMA, Drug: 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617All patients diagnosed with ACC underwent 68Ga-PSMA PET/CT scan. If the PET/CT showed high PSMA expression in tumor lesions of some patients, they would intravenously injected with the dose about 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617 for therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- confirmed treated or untreated adenoid cystic carcinoma patients;
- 18F-FDG PET/CT within two weeks;
- signed written consent.
Key exclusion criteria (4 listed)
- pregnancy;
- breastfeeding;
- known allergy against PSMA
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance
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 |
|---|---|---|
| 68Ga-PSMAAlso: 68Ga-prostate specific membrane antigenIntravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-PSMA. Tracer doses of 68Ga-PSMA will be used to image lesions of adenoid cystic carcinoma by PET/CT. | Drug | 68Ga-PSMA, PET/CT and 177Lu-EB-PSMA-617 therapy |
| 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617Patients were intravenous injected with the dose about 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles. | Drug | 68Ga-PSMA, PET/CT and 177Lu-EB-PSMA-617 therapy |
Primary outcome
Diagnostic value
Time frame: through study completion, an average of 1 year
Sensitivity and Specificity of 68Ga-PSMA PET/CT for adenoid cystic carcinoma in comparison with 18F-FDG PET/CT
1 secondary outcome
Safety of therapy
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Derived from this study: PubMed 35984529Wang G, Zhou M, Zang J, Jiang Y, Chen X, Zhu Z, Chen X. A pilot study of 68 Ga-PSMA-617 PET/CT imaging and 177Lu-EB-PSMA-617 radioligand therapy in patients with adenoid cystic carcinoma. EJNMMI Res. 2022 Aug 19;12(1):52. doi: 10.1186/s13550-022-00922-x.
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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.
Zhaohui Zhu, MD principal investigator
Peking Union Medical College Hospital
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 68Ga-PSMA and 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617 in people with Adenoid Cystic Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 23 Mar 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaohui Zhu, MD (86-13611093752, 13611093752@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic value (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04801264, which also lists 1 linked publication.
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 23 Mar 2021.